BACKGROUND:Maternal nutrition during pregnancy is known to have an effect on fetal growth and development. It is recommended that women increase their calcium intake during pregnancy and lactation, although the recommended dosage varies among professionals. Currently, there is no consensus on the role of routine calcium supplementation for pregnant women other than for preventing or treating hypertension. OBJECTIVES:To determine the effect of calcium supplementation on maternal, fetal and neonatal outcomes, excluding women with multiple gestation (other than for preventing or treating hypertension), including the occurrence of adverse effects. SEARCH METHODS:We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (which includes results of comprehensive searches of CENTRAL, MEDLINE, Embase, CINAHL, two trials registers and relevant conference proceedings) on 3 December 2022. We also searched the reference lists of retrieved studies. SELECTION CRITERIA:We considered all published, unpublished and ongoing randomised controlled trials (RCTs) comparing maternal, fetal and neonatal outcomes in pregnant women who received calcium supplementation versus placebo or no treatment. Cluster-RCTs were eligible for inclusion but none were identified. Quasi-RCTs and cross-over studies were not eligible for inclusion. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for inclusion. At least one review author assessed trials meeting the inclusion criteria for trustworthiness, consulting another review author in cases that were not immediately clear. Two review authors independently assessed the studies for risk of bias, extracted data, and checked trials for accuracy. We assessed the certainty of the evidence using GRADE. MAIN RESULTS:Twenty-one studies met the inclusion criteria, but only 19 studies contributed data to the review. These 19 trials recruited 17,370 women, with 16,625 women included in the final analyses. The trials were generally at low risk of bias for randomisation and allocation concealment. We chose three outcomes for GRADE assessment: preterm birth less than 37 weeks, preterm birth less than 34 weeks and low birthweight (less than 2500 g). All trials compared calcium supplementation with placebo or no treatment with 17 trials comparing high-dose calcium (greater than 1000 mg/day). Calcium supplementation probably slightly reduces the risk of preterm birth less than 37 weeks (average risk ratio (RR) 0.80, 95% confidence interval (CI) 0.65 to 0.99; 11 trials, 15,379 women; moderate-certainty evidence), but probably has little effect on the risk of preterm birth less than 34 weeks (average RR 1.03, 95% CI 0.79 to 1.35; 3 trials, 5569 women; moderate-certainty evidence), and may have little or no effect on low birthweight (less than 2500 g) (average RR 0.93, 95% CI 0.81 to 1.07; 6 trials, 14,162 women; low-certainty evidence; 1 study reported low birthweight (less than 2500 g) but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 5 studies rather than 6). We downgraded the evidence for imprecision (wide CIs crossing the line of no effect) and inconsistency (high levels of heterogeneity between the studies). There was no evidence that calcium supplementation had any effect on maternal weight gain during pregnancy; increasing bone mineral density in pregnant women; rate of intrauterine growth restriction; perinatal mortality; stillbirth or fetal death rate; increase birth length or fetal head circumference; and adverse effects such as postpartum haemorrhage, gall stones, gastrointestinal symptoms, headache, urinary stones, urinary tract infection or impaired renal function. AUTHORS' CONCLUSIONS:This review indicates that calcium supplementation probably reduces preterm birth before 37 weeks. There are no clear additional benefits to calcium supplementation in preterm birth before 34 weeks or prevention of low birthweight. Large multicentre trials to detect the effect of calcium supplementation on fetal birthweight and preterm birth before 34 weeks as the primary outcomes are needed. Further research into the short- and long-term effects of calcium supplementation would also be beneficial.

BACKGROUND:Iron and folic acid supplementation have been recommended in pregnancy for anaemia prevention, and may improve other maternal, pregnancy, and infant outcomes. OBJECTIVES:To examine the effects of daily oral iron supplementation during pregnancy, either alone or in combination with folic acid or with other vitamins and minerals, as an intervention in antenatal care. SEARCH METHODS:We searched the Cochrane Pregnancy and Childbirth Trials Registry on 18 January 2024 (including CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO's International Clinical Trials Registry Platform, conference proceedings), and searched reference lists of retrieved studies. SELECTION CRITERIA:Randomised or quasi-randomised trials that evaluated the effects of oral supplementation with daily iron, iron + folic acid, or iron + other vitamins and minerals during pregnancy were included. DATA COLLECTION AND ANALYSIS:Review authors independently assessed trial eligibility, ascertained trustworthiness based on pre-defined criteria, assessed risk of bias, extracted data, and conducted checks for accuracy. We used the GRADE approach to assess the certainty of the evidence for primary outcomes. We anticipated high heterogeneity amongst trials; we pooled trial results using a random-effects model (average treatment effect). MAIN RESULTS:We included 57 trials involving 48,971 women. A total of 40 trials compared the effects of daily oral supplements with iron to placebo or no iron; eight trials evaluated the effects of iron + folic acid compared to placebo or no iron + folic acid. Iron supplementation compared to placebo or no iron Maternal outcomes: Iron supplementation during pregnancy may reduce maternal anaemia (4.0% versus 7.4%; risk ratio (RR) 0.30, 95% confidence interval (CI) 0.20 to 0.47; 14 trials, 13,543 women; low-certainty evidence) and iron deficiency at term (44.0% versus 66.0%; RR 0.51, 95% CI 0.38 to 0.68; 8 trials, 2873 women; low-certainty evidence), and probably reduces maternal iron-deficiency anaemia at term (5.0% versus 18.4%; RR 0.41, 95% CI 0.26 to 0.63; 7 trials, 2704 women; moderate-certainty evidence), compared to placebo or no iron supplementation. There is probably little to no difference in maternal death (2 versus 4 events, RR 0.57, 95% CI 0.12 to 2.69; 3 trials, 14,060 women; moderate-certainty evidence). The evidence is very uncertain for adverse effects (21.6% versus 18.0%; RR 1.29, 95% CI 0.83 to 2.02; 12 trials, 2423 women; very low-certainty evidence) and severe anaemia (Hb < 70 g/L) in the second/third trimester (< 1% versus 3.6%; RR 0.22, 95% CI 0.01 to 3.20; 8 trials, 1398 women; very low-certainty evidence). No trials reported clinical malaria or infection during pregnancy. Infant outcomes: Women taking iron supplements are probably less likely to have infants with low birthweight (5.2% versus 6.1%; RR 0.84, 95% CI 0.72 to 0.99; 12 trials, 18,290 infants; moderate-certainty evidence), compared to placebo or no iron supplementation. However, the evidence is very uncertain for infant birthweight (MD 24.9 g, 95% CI -125.81 to 175.60; 16 trials, 18,554 infants; very low-certainty evidence). There is probably little to no difference in preterm birth (7.6% versus 8.2%; RR 0.93, 95% CI 0.84 to 1.02; 11 trials, 18,827 infants; moderate-certainty evidence) and there may be little to no difference in neonatal death (1.4% versus 1.5%, RR 0.98, 95% CI 0.77 to 1.24; 4 trials, 17,243 infants; low-certainty evidence) or congenital anomalies, including neural tube defects (41 versus 48 events; RR 0.88, 95% CI 0.58 to 1.33; 4 trials, 14,377 infants; low-certainty evidence). Iron + folic supplementation compared to placebo or no iron + folic acid Maternal outcomes: Daily oral supplementation with iron + folic acid probably reduces maternal anaemia at term (12.1% versus 25.5%; RR 0.44, 95% CI 0.30 to 0.64; 4 trials, 1962 women; moderate-certainty evidence), and may reduce maternal iron deficiency at term (3.6% versus 15%; RR 0.24, 95% CI 0.06 to 0.99; 1 trial, 131 women; low-certainty evidence), compared to placebo or no iron + folic acid. The evidence is very uncertain about the effects of iron + folic acid on maternal iron-deficiency anaemia (10.8% versus 25%; RR 0.43, 95% CI 0.17 to 1.09; 1 trial, 131 women; very low-certainty evidence), or maternal deaths (no events; 1 trial; very low-certainty evidence). The evidence is uncertain for adverse effects (21.0% versus 0.0%; RR 44.32, 95% CI 2.77 to 709.09; 1 trial, 456 women; low-certainty evidence), and the evidence is very uncertain for severe anaemia in the second or third trimester (< 1% versus 5.6%; RR 0.12, 95% CI 0.02 to 0.63; 4 trials, 506 women; very low-certainty evidence), compared to placebo or no iron + folic acid. Infant outcomes: There may be little to no difference in infant low birthweight (33.4% versus 40.2%; RR 1.07, 95% CI 0.31 to 3.74; 2 trials, 1311 infants; low-certainty evidence), comparing iron + folic acid supplementation to placebo or no iron + folic acid. Infants born to women who received iron + folic acid during pregnancy probably had higher birthweight (MD 57.73 g, 95% CI 7.66 to 107.79; 2 trials, 1365 infants; moderate-certainty evidence), compared to placebo or no iron + folic acid. There may be little to no difference in other infant outcomes, including preterm birth (19.4% versus 19.2%; RR 1.55, 95% CI 0.40 to 6.00; 3 trials, 1497 infants; low-certainty evidence), neonatal death (3.4% versus 4.2%; RR 0.81, 95% CI 0.51 to 1.30; 1 trial, 1793 infants; low-certainty evidence), or congenital anomalies (1.7% versus 2.4; RR 0.70, 95% CI 0.35 to 1.40; 1 trial, 1652 infants; low-certainty evidence), comparing iron + folic acid supplementation to placebo or no iron + folic acid. A total of 19 trials were conducted in malaria-endemic countries, or in settings with some malaria risk. No studies reported maternal clinical malaria; one study reported data on placental malaria. AUTHORS' CONCLUSIONS:Daily oral iron supplementation during pregnancy may reduce maternal anaemia and iron deficiency at term. For other maternal and infant outcomes, there was little to no difference between groups or the evidence was uncertain. Future research is needed to examine the effects of iron supplementation on other maternal and infant health outcomes, including infant iron status, growth, and development.

Abstract Background There is increasing concern that a significant proportion of randomized controlled trials (RCTs) included in Cochrane reviews may not be trustworthy. Applying the Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool (CPC‐TST) has already had a clinically important effect on several reviews published by the Cochrane Pregnancy and Childbirth Group. Objectives We wanted to assess the impact of removing untrustworthy RCTs from already‐published Cochrane reviews on a defined clinical area (antenatal and postnatal nutritional interventions). Methods We applied the tool to 18 Cochrane reviews (374 RCTs). The tool had four domains: (i) is the research governance trustworthy; (ii) are the baseline characteristics trustworthy; (iii) is the study feasible; (iv) are the results plausible? When additional information was needed, authors were contacted using a standard template. At least two attempts were made to contact the authors. At the end of the evaluation process each study was classified as: (i) included (YES to all questions); (ii) excluded (retracted study); or (iii) awaiting classification (any NO to the questions). Results Ninety‐three out of 374 included studies (25%) were reclassified as “excluded” or “awaiting classification.” The number of included RCTs was reduced in 14 out of 18 reviews. Six reviews (33%) were judged to require updating because of important differences in the Summary of Findings tables (direction and size of effects and/or GRADE ratings), conclusions, implication for practice, and/or implication for research. Conclusions Formal assessment of trustworthiness, and inclusion only of studies that satisfy prespecified criteria for trustworthiness, affect conclusions in a relatively large number of Cochrane reviews, with potentially important clinical implications for practice and research.

Building a dataset of individual participant data (IPD) for meta-analysis represents considerable research investment as well as collaboration across multiple institutions and researchers. Making arrangements to curate and share the dataset beyond the IPD meta-analysis project for which it was established, for reuse in future research projects, would maximise the value of this investment.Our aim was to establish the Cochrane repository for individual patient data from clinical trials in pregnancy and childbirth (CRIB) as an example of how an IPD repository could become part of Cochrane infrastructure. We believed that establishing CRIB under Cochrane auspices would engender trust and encourage trial investigators to share data, and at the same time position Cochrane to take steps towards expanding the number of reviews with IPD synthesis.CRIB was designed as a web-based platform to receive, host and facilitate onward sharing of de-identified data. Development was not straightforward and we did not fully achieve our aim as intended. We describe the challenges encountered and suggest ways that future repositories might overcome these. In particular, securing the legal agreements required to facilitate data sharing proved to be the main barrier, being time-consuming and more complex than anticipated.We would recommend that researchers conducting IPD meta-analysis should consider discussing the option to transfer the curated IPD datasets to a repository at the end of the initial meta-analysis and this should be recognised within the data sharing agreements made with the original data contributors.

BACKGROUND:Misoprostol given orally is a commonly used labour induction method. Our Cochrane Review is restricted to studies with low-dose misoprostol (initially ≤ 50 µg), as higher doses pose unacceptably high risks of uterine hyperstimulation. OBJECTIVES:To assess the efficacy and safety of low-dose oral misoprostol for labour induction in women with a viable fetus in the third trimester of pregnancy. SEARCH METHODS:We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov,  the WHO International Clinical Trials Registry Platform (14 February 2021) and reference lists of retrieved studies. SELECTION CRITERIA:Randomised trials comparing low-dose oral misoprostol (initial dose ≤ 50 µg) versus placebo, vaginal dinoprostone, vaginal misoprostol, oxytocin, or mechanical methods; or comparing oral misoprostol protocols (one- to two-hourly versus four- to six-hourly; 20 µg to 25 µg versus 50 µg; or 20 µg hourly titrated versus 25 µg two-hourly static). DATA COLLECTION AND ANALYSIS:Using Covidence, two review authors independently screened reports, extracted trial data, and performed quality assessments. Our primary outcomes were vaginal birth within 24 hours, caesarean section, and hyperstimulation with foetal heart changes. MAIN RESULTS:We included 61 trials involving 20,026 women. GRADE assessments ranged from moderate- to very low-certainty evidence, with downgrading decisions based on imprecision, inconsistency, and study limitations. Oral misoprostol versus placebo/no treatment (four trials; 594 women) Oral misoprostol may make little to no difference in the rate of caesarean section (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.11; 4 trials; 594 women; moderate-certainty evidence), while its effect on uterine hyperstimulation with foetal heart rate changes is uncertain (RR 5.15, 95% CI 0.25 to 105.31; 3 trials; 495 women; very low-certainty evidence). Vaginal births within 24 hours was not reported. In all trials, oxytocin could be commenced after 12 to 24 hours and all women had pre-labour ruptured membranes. Oral misoprostol versus vaginal dinoprostone (13 trials; 9676 women) Oral misoprostol probably results in fewer caesarean sections (RR 0.84, 95% CI 0.78 to 0.90; 13 trials, 9676 women; moderate-certainty evidence). Subgroup analysis indicated that 10 µg to 25 µg (RR 0.80, 95% CI 0.74 to 0.87; 9 trials; 8652 women) may differ from 50 µg (RR 1.10, 95% CI 0.91 to 1.34; 4 trials; 1024 women) for caesarean section. Oral misoprostol may decrease vaginal births within 24 hours (RR 0.93, 95% CI 0.87 to 1.00; 10 trials; 8983 women; low-certainty evidence) and hyperstimulation with foetal heart rate changes (RR 0.49, 95% CI 0.40 to 0.59; 11 trials; 9084 women; low-certainty evidence). Oral misoprostol versus vaginal misoprostol (33 trials; 6110 women) Oral use may result in fewer vaginal births within 24 hours (average RR 0.81, 95% CI 0.68 to 0.95; 16 trials, 3451 women; low-certainty evidence), and less hyperstimulation with foetal heart rate changes (RR 0.69, 95% CI 0.53 to 0.92, 25 trials, 4857 women, low-certainty evidence), with subgroup analysis suggesting that 10 µg to 25 µg orally (RR 0.28, 95% CI 0.14 to 0.57; 6 trials, 957 women) may be superior to 50 µg orally (RR 0.82, 95% CI 0.61 to 1.11; 19 trials; 3900 women). Oral misoprostol probably does not increase caesarean sections overall (average RR 1.00, 95% CI 0.86 to 1.16; 32 trials; 5914 women; low-certainty evidence) but likely results in fewer caesareans for foetal distress (RR 0.74, 95% CI 0.55 to 0.99; 24 trials, 4775 women). Oral misoprostol versus intravenous oxytocin (6 trials; 737 women, 200 with ruptured membranes) Misoprostol may make little or no difference to vaginal births within 24 hours (RR 1.12, 95% CI 0.95 to 1.33; 3 trials; 466 women; low-certainty evidence), but probably results in fewer caesarean sections (RR 0.67, 95% CI 0.50 to 0.90; 6 trials; 737 women; moderate-certainty evidence). The effect on hyperstimulation with foetal heart rate changes is uncertain (RR 0.66, 95% CI 0.19 to 2.26; 3 trials, 331 women; very low-certainty evidence). Oral misoprostol versus mechanical methods (6 trials; 2993 women) Six trials compared oral misoprostol to transcervical Foley catheter. Misoprostol may increase vaginal birth within 24 hours (RR 1.32, 95% CI 0.98 to 1.79; 4 trials; 1044 women; low-certainty evidence), and probably reduces the risk of caesarean section (RR 0.84, 95% CI 0.75 to 0.95; 6 trials; 2993 women; moderate-certainty evidence). There may be little or no difference in hyperstimulation with foetal heart rate changes (RR 1.31, 95% CI 0.78 to 2.21; 4 trials; 2828 women; low-certainty evidence). Oral misoprostol one- to two-hourly versus four- to six-hourly (1 trial; 64 women) The evidence on hourly titration was very uncertain due to the low numbers reported. Oral misoprostol 20 µg hourly titrated versus 25 µg two-hourly static (2 trials; 296 women) The difference in regimen may have little or no effect on the rate of vaginal births in 24 hours (RR 0.97, 95% CI 0.80 to 1.16; low-certainty evidence). The evidence is of very low certainty for all other reported outcomes. AUTHORS' CONCLUSIONS:Low-dose oral misoprostol is probably associated with fewer caesarean sections (and therefore more vaginal births) than vaginal dinoprostone, and lower rates of hyperstimulation with foetal heart rate changes. However, time to birth may be increased, as seen by a reduced number of vaginal births within 24 hours. Compared to transcervical Foley catheter, low-dose oral misoprostol is associated with fewer caesarean sections, but equivalent rates of hyperstimulation. Low-dose misoprostol given orally rather than vaginally is probably associated with similar rates of vaginal birth, although rates may be lower within the first 24 hours. However, there is likely less hyperstimulation with foetal heart changes, and fewer caesarean sections performed due to foetal distress. The best available evidence suggests that low-dose oral misoprostol probably has many benefits over other methods for labour induction. This review supports the use of low-dose oral misoprostol for induction of labour, and demonstrates the lower risks of hyperstimulation than when misoprostol is given vaginally. More trials are needed to establish the optimum oral misoprostol regimen, but these findings suggest that a starting dose of 25 µg may offer a good balance of efficacy and safety.

Background Building a dataset of individual participant data (IPD) for meta-analysis represents considerable research investment as well as collaboration across multiple institutions and researchers. Making arrangements to curate and share the dataset beyond the IPD meta-analysis project for which it was established, for reuse in future research projects, would maximise the value of this investment. Methods Our aim was to establish the Cochrane repository for individual patient data from clinical trials in pregnancy and childbirth (CRIB) as an example of how an IPD repository could become part of Cochrane infrastructure. We believed that establishing CRIB under Cochrane auspices would engender trust and encourage trial investigators to share data, and at the same time position Cochrane to take steps towards expanding the number of reviews with IPD synthesis. Results CRIB was designed as a web-based platform to receive, host and facilitate onward sharing of de-identified data. Development was not straightforward and we did not fully achieve our aim as intended. We describe the challenges encountered and suggest ways that future repositories might overcome these. In particular, securing the legal agreements required to facilitate data sharing proved to be the main barrier, being time-consuming and more complex than anticipated. Conclusions We would recommend that researchers conducting IPD meta-analysis should consider discussing the option to transfer the curated IPD datasets to a repository at the end of the initial meta-analysis and this should be recognised within the data sharing agreements made with the original data contributors.

BACKGROUND:Active management of the third stage of labour reduces the risk of postpartum blood loss (postpartum haemorrhage (PPH)), and is defined as administration of a prophylactic uterotonic, early umbilical cord clamping and controlled cord traction to facilitate placental delivery. The choice of uterotonic varies across the globe and may have an impact on maternal outcomes. This is an update of a review first published in 2001 and last updated in 2013. OBJECTIVES:To determine the effectiveness of prophylactic oxytocin to prevent PPH and other adverse maternal outcomes in the third stage of labour. SEARCH METHODS:For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) (6 March 2019) and reference lists of retrieved studies. SELECTION CRITERIA:Randomised, quasi- or cluster-randomised trials including women undergoing vaginal delivery who received prophylactic oxytocin during management of the third stage of labour. Primary outcomes were blood loss 500 mL or more after delivery, need for additional uterotonics, and maternal all-cause mortality. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for inclusion, extracted data, and assessed trial quality. Data were checked for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS:This review includes 24 trials, with 23 trials involving 10,018 women contributing data. Due to many trials assessed at high risk of bias, evidence grade ranged from very low to moderate quality.Prophylactic oxytocin versus no uterotonics or placebo (nine trials)Prophylactic oxytocin compared with no uterotonics or placebo may reduce the risk of blood loss of 500 mL after delivery (average risk ratio (RR) 0.51, 95% confidence interval (C) 0.37 to 0.72; 4162 women; 6 studies; Tau² = 0.10, I² = 75%; low-quality evidence), and blood loss 1000 mL after delivery (RR 0.59, 95% CI 0.42 to 0.83; 4123 women; 5 studies; low-quality evidence). Prophylactic oxytocin probably reduces the need for additional uterotonics (average RR 0.54, 95% CI 0.36 to 0.80; 3135 women; 4 studies; Tau² = 0.07, I² = 44%; moderate-quality evidence). There may be no difference in the risk of needing a blood transfusion in women receiving oxytocin compared to no uterotonics or placebo (RR 0.88, 95% CI 0.44 to 1.78; 3081 women; 3 studies; low-quality evidence). Oxytocin may be associated with an increased risk of a third stage greater than 30 minutes (RR 2.55, 95% CI 0.88 to 7.44; 1947 women; 1 study; moderate-quality evidence), however the confidence interval is wide and includes 1.0, indicating that there may be little or no difference.Prophylactic oxytocin versus ergot alkaloids (15 trials)It is uncertain whether oxytocin reduces the likelihood of blood loss 500 mL (average RR 0.84, 95% CI 0.56 to 1.25; 3082 women; 10 studies; Tau² = 0.14, I² = 49%; very low-quality evidence) or the need for additional uterotonics compared to ergot alkaloids (average RR 0.89, 95% CI 0.43 to 1.81; 2178 women; 8 studies; Tau² = 0.76, I² = 79%; very low-quality evidence), because the quality of this evidence is very low. The quality of evidence was very low for blood loss of 1000 mL (RR 1.13, 95% CI 0.63 to 2.01; 1577 women; 3 studies; very low-quality evidence), and need for blood transfusion (average RR 1.37, 95% CI 0.34 to 5.51; 1578 women; 7 studies; Tau² = 1.34, I² = 45%; very low-quality evidence), making benefit of oxytocin over ergot alkaloids uncertain. Oxytocin probably increases the risk of a prolonged third stage greater than 30 minutes (RR 4.69, 95% CI 1.63 to 13.45; 450 women; 2 studies; moderate-quality evidence), although it is uncertain if this translates into increased risk of manual placental removal (average RR 1.10, 95% CI 0.39 to 3.10; 3127 women; 8 studies; Tau² = 1.07, I² = 76%; very low-quality evidence). Oxytocin may make little or no difference to risk of diastolic blood pressure > 100 mm Hg (average RR 0.28, 95% CI 0.04 to 2.05; 960 women; 3 studies; Tau² = 1.23, I² = 50%; low-quality evidence), and is probably associated with a lower risk of vomiting (RR 0.09, 95% CI 0.05 to 0.14; 1991 women; 7 studies; moderate-quality evidence), although the impact of oxytocin on headaches is uncertain (average RR 0.19, 95% CI 0.03 to 1.02; 1543 women; 5 studies; Tau² = 2.54, I² = 72%; very low-quality evidence).Prophylactic oxytocin-ergometrine versus ergot alkaloids (four trials)Oxytocin-ergometrine may slightly reduce the risk of blood loss greater than 500 mL after delivery compared to ergot alkaloids (RR 0.44, 95% CI 0.20 to 0.94; 1168 women; 3 studies; low-quality evidence), based on outcomes from quasi-randomised trials with a high risk of bias. There were no maternal deaths reported in either treatment group in the one trial that reported this outcome (RR not estimable; 1 trial, 807 women; moderate-quality evidence). Need for additional uterotonics was not reported.No subgroup differences were observed between active or expectant management, or different routes or doses of oxytocin for any of our comparisons. AUTHORS' CONCLUSIONS:Prophylactic oxytocin compared with no uterotonics may reduce blood loss and the need for additional uterotonics. The effect of oxytocin compared to ergot alkaloids is uncertain with regards to blood loss, need for additional uterotonics, and blood transfusion. Oxytocin may increase the risk of a prolonged third stage compared to ergot alkaloids, although whether this translates into increased risk of manual placental removal is uncertain. This potential risk must be weighed against the possible increased risk of side effects associated with ergot alkaloids. Oxytocin-ergometrine may reduce blood loss compared to ergot alkaloids, however the certainty of this conclusion is low. More high-quality trials are needed to assess optimal dosing and route of oxytocin administration, with inclusion of important outcomes such as maternal mortality, shock, and transfer to a higher level of care. A network meta-analysis of uterotonics for PPH prevention plans to address issues around optimal dosing and routes of oxytocin and other uterotonics.

BACKGROUND: Enthusiasts suggest that labouring in water and waterbirth increase maternal relaxation, reduce analgesia requirements and promote a midwifery model of care. Critics cite the risk of neonatal water inhalation and maternal/neonatal infection. OBJECTIVES: To assess the evidence from randomised controlled trials about immersion in water during labour and waterbirth on maternal, fetal, neonatal and caregiver outcomes. METHODS: Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2011) and reference lists of retrieved studies. Selection criteria: Randomised controlled trials comparing immersion in any bath tub/pool with no immersion, or other non-pharmacological forms of pain management during labour and/or birth, in women during labour who were considered to be at low risk of complications, as defined by the researchers. Data collection and analysis: We assessed trial eligibility and quality and extracted data independently. One review author entered data and the other checked for accuracy. MAIN RESULTS: This review includes 12 trials (3,243 women): 8 related to just the first stage of labour: one to early versus late immersion in the first stage of labour; two to the first and second stages; and another to the second stage only. We identified no trials evaluating different baths/pools, or the management of third stage of labour. Results for the first stage of labour showed there was a significant reduction in the epidural/spinal/paracervical analgesia/anaesthesia rate amongst women allocated to water immersion compared to controls (478/1,254 versus 529/1,245; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.82 to 0.99, six trials). There was also a reduction in duration of the first stage of labour (mean difference -32.4 minutes; 95% CI -58.7 to -6.13). There was no difference in assisted vaginal deliveries (RR 0.86; 95% CI 0.71 to 1.05, seven trials), caesarean sections (RR 1.21; 95% CI 0.87 to 1.68, 8 trials), use of oxytocin infusion (RR 0.64; 95% CI 0.32 to 1.28, 5 trials), perineal trauma or maternal infection. There were no differences for Apgar score less than 7 at 5 minutes (RR 1.58; 95% CI 0.63 to 3.93, 5 trials), neonatal unit admissions (RR 1.06; 95% CI 0.71 to 1.57, three trials), or neonatal infection rates (RR 2.00; 95% CI 0.50 to 7.94, five trials). Of the 3 trials that compared water immersion during the second stage with no immersion, one trial showed a significantly higher level of satisfaction with the birth experience (RR 0.24; 95% CI 0.07 to 0.80). A lack of data for some comparisons prevented robust conclusions. Further research is needed. AUTHORS' CONCLUSIONS: Evidence suggests that water immersion during the first stage of labour reduces the use of epidural/spinal analgesia and duration of the first stage of labour. There is limited information for other outcomes related to water use during the first and second stages of labour, due to intervention and outcome variability. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring in water or waterbirth. However, the studies are very variable and considerable heterogeneity was detected for some outcomes. Further research is needed.

BACKGROUND:Water immersion during labour and birth is increasingly popular and is becoming widely accepted across many countries, and particularly in midwifery-led care settings. However, there are concerns around neonatal water inhalation, increased requirement for admission to neonatal intensive care unit (NICU), maternal and/or neonatal infection, and obstetric anal sphincter injuries (OASIS). This is an update of a review last published in 2011. OBJECTIVES:To assess the effects of water immersion during labour and/or birth (first, second and third stage of labour) on women and their infants. SEARCH METHODS:We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (18 July 2017), and reference lists of retrieved trials. SELECTION CRITERIA:We included randomised controlled trials (RCTs) comparing water immersion with no immersion, or other non-pharmacological forms of pain management during labour and/or birth in healthy low-risk women at term gestation with a singleton fetus. Quasi-RCTs and cluster-RCTs were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. MAIN RESULTS:This review includes 15 trials conducted between 1990 and 2015 (3663 women): eight involved water immersion during the first stage of labour; two during the second stage only; four during the first and second stages of labour, and one comparing early versus late immersion during the first stage of labour. No trials evaluated different baths/pools, or third-stage labour management. All trials were undertaken in a hospital labour ward setting, with a varying degree of medical intervention considered as routine practice. No study was carried out in a midwifery-led care setting. Most trial authors did not specify the parity of women. Trials were subject to varying degrees of bias: the intervention could not be blinded and there was a lack of information about randomisation, and whether analyses were undertaken by intention-to-treat.Immersion in water versus no immersion (first stage of labour)There is probably little or no difference in spontaneous vaginal birth between immersion and no immersion (82% versus 83%; risk ratio (RR) 1.01, 95% confidence interval (CI) 0.97 to 1.04; 6 trials; 2559 women; moderate-quality evidence); instrumental vaginal birth (14% versus 12%; RR 0.86, 95% CI 0.70 to 1.05; 6 trials; 2559 women; low-quality evidence); and caesarean section (4% versus 5%; RR 1.27, 95% CI 0.91 to 1.79; 7 trials; 2652 women; low-quality evidence). There is insufficient evidence to determine the effect of immersion on estimated blood loss (mean difference (MD) -14.33 mL, 95% CI -63.03 to 34.37; 2 trials; 153 women; very low-quality evidence) and third- or fourth-degree tears (3% versus 3%; RR 1.36, 95% CI 0.85 to 2.18; 4 trials; 2341 women; moderate-quality evidence). There was a small reduction in the risk of using regional analgesia for women allocated to water immersion from 43% to 39% (RR 0.91, 95% CI 0.83 to 0.99; 5 trials; 2439 women; moderate-quality evidence). Perinatal deaths were not reported, and there is insufficient evidence to determine the impact on neonatal intensive care unit (NICU) admissions (6% versus 8%; average RR 1.30, 95% CI 0.42 to 3.97; 2 trials; 1511 infants; I² = 36%; low-quality evidence), or on neonatal infection rates (1% versus 1%; RR 2.00, 95% CI 0.50 to 7.94; 5 trials; 1295 infants; very low-quality evidence).Immersion in water versus no immersion (second stage of labour)There were no clear differences between groups for spontaneous vaginal birth (97% versus 99%; RR 1.02, 95% CI 0.96 to 1.08; 120 women; 1 trial; low-quality evidence); instrumental vaginal birth (2% versus 2%; RR 1.00, 95% CI 0.06 to 15.62; 1 trial; 120 women; very low-quality evidence); caesarean section (2% versus 1%; RR 0.33, 95% CI 0.01 to 8.02; 1 trial; 120 women; very low-quality evidence), and NICU admissions (11% versus 9%; RR 0.78, 95% CI 0.38 to 1.59; 2 trials; 291 women; very low-quality evidence). Use of regional analgesia was not relevant to the second stage of labour. Third- or fourth-degree tears, and estimated blood loss were not reported in either trial. No trial reported neonatal infection but did report neonatal temperature less than 36.2°C at birth (9% versus 9%; RR 0.98, 95% CI 0.30 to 3.20; 1 trial; 109 infants; very low-quality evidence), greater than 37.5°C at birth (6% versus 15%; RR 2.62, 95% CI 0.73 to 9.35; 1 trial; 109 infants; very low-quality evidence), and fever reported in first week (5% versus 2%; RR 0.53, 95% CI 0.10 to 2.82; 1 trial; 171 infants; very low-quality evidence), with no clear effect between groups being observed. One perinatal death occurred in the immersion group in one trial (RR 3.00, 95% CI 0.12 to 72.20; 1 trial; 120 infants; very low-quality evidence). The infant was born to a mother with HIV and the cause of death was deemed to be intrauterine infection.There is no evidence of increased adverse effects to the baby or woman from either the first or second stage of labour.Only one trial (200 women) compared early and late entry into the water and there were insufficient data to show any clear differences. AUTHORS' CONCLUSIONS:In healthy women at low risk of complications there is moderate to low-quality evidence that water immersion during the first stage of labour probably has little effect on mode of birth or perineal trauma, but may reduce the use of regional analgesia. The evidence for immersion during the second stage of labour is limited and does not show clear differences on maternal or neonatal outcomes intensive care. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring or giving birth in water. Available evidence is limited by clinical variability and heterogeneity across trials, and no trial has been conducted in a midwifery-led setting.

Background The partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. This review is an update of a review last published in 2013. Objectives The primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes. Search methods We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), Cl in icalTi ial s.gav, the World Health Organization (WHO) International Clinical Trials Registry Platform ( ICTRP) (31 August 2017) and reference lists of retrieved studies. Selection criteria Randomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs. Data collection and analysis Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach. Main results We have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates. Most trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth). Partograph versus no partograph (3 trials, 1813 women) It is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I-2 = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI-0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I-2 = 87%; very low-quality evidence). Partograph with different placement of action lines (4 trials, 5051 women) When compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; 12 = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I-2 = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line. The following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the twohour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons. Partograph with alert line only versus partograph with alert and action line (1 trial, 694 women) The caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death. Partograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women) The caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes. Partograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women) Fewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison. Partograph versus labour scale (1 trial, 122 women) The use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes. Authors' conclusions On the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.

Un soutien continu pendant le travail peut ameliorer les resultats pour les femmes et les nourrissons, notamment une augmentation de la naissance vaginale spontanee, une duree plus courte du travail et une diminution du nombre de cesariennes, une naissance vaginale instrumentale, l'utilisation de toute analgesie, l'utilisation de l'analgesie regionale, un score faible de Apgar de cinq minutes et un score negatif. sentiments au sujet des experiences d'accouchement.

BACKGROUND Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011. OBJECTIVES To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour. SEARCH METHODS We searched Cochrane Pregnancy and Childbirth's Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies. SELECTION CRITERIA Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster-randomised or quasi-randomised trials in this update. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach. MAIN RESULTS Fifty-two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty-four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu-stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference -2.64, 95% confidence interval (CI) -4.56 to -0.73; 1133 women; studies = 5; I2 = 98%; low-quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I2 = 97%; low-quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I2 = 73%; Tau2 = 1.89; Chi2 = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low-quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate-quality evidence), and maternal long-term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate-quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate-quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low-quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long-term neonatal outcomes were not reported.Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu-stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects. AUTHORS' CONCLUSIONS Low-quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long-term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non-epidural analgesia on women in labour and long-term neonatal outcomes.

BACKGROUND:Pelvimetry assesses the size of a woman's pelvis aiming to predict whether she will be able to give birth vaginally or not. This can be done by clinical examination, or by conventional X-rays, computerised tomography (CT) scanning, or magnetic resonance imaging (MRI). OBJECTIVES:To assess the effects of pelvimetry (performed antenatally or intrapartum) on the method of birth, on perinatal mortality and morbidity, and on maternal morbidity. This review concentrates exclusively on women whose fetuses have a cephalic presentation. SEARCH METHODS:We searched Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2017) and reference lists of retrieved studies. SELECTION CRITERIA:Randomised controlled trials (including quasi-randomised) assessing the use of pelvimetry versus no pelvimetry or assessing different types of pelvimetry in women with a cephalic presentation at or near term were included. Cluster trials were eligible for inclusion, but none were identified. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS:Five trials with a total of 1159 women were included. All used X-ray pelvimetry to assess the pelvis. X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that examined other types of radiological pelvimetry or that compared clinical pelvimetry versus no pelvimetry.The included trials were generally at high risk of bias. There is an overall high risk of performance bias due to lack of blinding of women and staff. Two studies were also at high risk of selection bias. We used GRADEpro software to grade evidence for our selected outcomes; for caesarean section we rated the evidence low quality and all the other outcomes (perinatal mortality, wound sepsis, blood transfusion, scar dehiscence and admission to special care baby unit) as very low quality. Downgrading was due to risk of bias relating to lack of allocation concealment and blinding, and imprecision of effect estimates.Women undergoing X-ray pelvimetry were more likely to have a caesarean section (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.19 to 1.52; 1159 women; 5 studies; low-quality evidence). There were no clear differences between groups for perinatal outcomes: perinatal mortality (RR 0.53, 95% CI 0.19 to 1.45; 1159 infants; 5 studies; very low-quality evidence), perinatal asphyxia (RR 0.66, 95% CI 0.39 to 1.10; 305 infants; 1 study), and admission to special care baby unit (RR 0.20, 95% CI 0.01 to 4.13; 288 infants; 1 study; very low-quality evidence). Other outcomes assessed were wound sepsis (RR 0.83, 95% CI 0.26 to 2.67; 288 women; 1 study; very low-quality evidence), blood transfusion (RR 1.00, 95% CI 0.39 to 2.59; 288 women; 1 study; very low-quality evidence), and scar dehiscence (RR 0.59, 95% CI 0.14 to 2.46; 390 women; 2 studies; very low-quality evidence). Again, no clear differences were found for these outcomes between the women who received X-ray pelvimetry and those who did not. Apgar score less than seven at five minutes was not reported in any study. AUTHORS' CONCLUSIONS:X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that used other types or pelvimetry (other radiological examination or clinical pelvimetry versus no pelvimetry). There is not enough evidence to support the use of X-ray pelvimetry for deciding on mode of delivery in women whose fetuses have a cephalic presentation. Women who undergo an X-ray pelvimetry may be more likely to have a caesarean section.Further research should be directed towards defining whether there are specific clinical situations in which pelvimetry can be shown to be of value. Newer methods of pelvimetry (CT, MRI) should be subjected to randomised trials to assess their value. Further trials of X-ray pelvimetry in cephalic presentations would be of value if large enough to assess the effect on perinatal mortality.

BACKGROUND Fundal pressure during the second stage of labour (also known as the 'Kristeller manoeuvre') involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal, in an attempt to assist spontaneous vaginal birth and avoid prolonged second stage or the need for operative birth. Fundal pressure has also been applied using an inflatable belt. Fundal pressure is widely used, however methods of its use vary widely. Despite strongly held opinions in favour of and against the use of fundal pressure, there is limited evidence regarding its maternal and neonatal benefits and harms. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour. OBJECTIVES To determine if fundal pressure is effective in achieving spontaneous vaginal birth, and preventing prolonged second stage or the need for operative birth, and to explore maternal and neonatal adverse effects related to fundal pressure. SEARCH METHODS We searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies. SELECTION CRITERIA Randomised and quasi-randomised controlled trials of fundal pressure (manual or by inflatable belt) versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation. DATA COLLECTION AND ANALYSIS Two or more review authors independently assessed potential studies for inclusion and quality. We extracted data using a pre-designed form. We entered data into Review Manager 5 software and checked for accuracy. MAIN RESULTS Nine trials are included in this updated review. Five trials (3057 women) compared manual fundal pressure versus no fundal pressure. Four trials (891 women) compared fundal pressure by means of an inflatable belt versus no fundal pressure. It was not possible to blind women and staff to this intervention. We assessed two trials as being at high risk of attrition bias and another at high risk of reporting bias. All other trials were low or unclear for other risk of bias domains. Most of the trials had design limitations. Heterogeneity was high for the majority of outcomes. Manual fundal pressure versus no fundal pressureManual fundal pressure was not associated with changes in: spontaneous vaginal birth within a specified time (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.71 to 1.28; 120 women; 1 trial; very low-quality evidence), instrumental births (RR 3.28, 95% CI 0.14 to 79.65; 197 women; 1 trial), caesarean births (RR 1.10, 95% CI 0.07 to 17.27; 197 women; 1 trial), operative birth (average RR 0.66, 95% CI 0.12 to 3.55; 317 women; 2 studies; I² = 43%; Tau² = 0.71; very low-quality evidence), duration of second stage (mean difference (MD) -0.80 minutes, 95% CI -3.66 to 2.06 minutes; 194 women; 1 study; very low-quality evidence), low arterial cord pH in newborn babies (RR 1.07, 95% CI 0.72 to 1.58; 297 women; 2 trials; very low-quality evidence), or Apgar scores less than seven at five minutes (average RR 4.48, 95% CI 0.28 to 71.45; 2759 infants; 4 trials; I² = 89%; Tau² = 3.55; very low-quality evidence). More women who received manual fundal pressure had cervical tears than in the control group (RR 4.90, 95% CI 1.09 to 21.98; 295 women; 1 trial). No neonatal deaths occurred in either of the two studies reporting this outcome (very low-quality evidence). No trial reported the outcome severe maternal morbidity or death. Fundal pressure by inflatable belt versus no fundal pressureFundal pressure by inflatable belt did not reduce the number of women havinginstrumental births (average RR 0.73, 95% CI 0.52 to 1.02; 891 women; 4 trials; I² = 52%; Tau² = 0.05) or operative births (average RR 0.62, 95% CI 0.38 to 1.01; 891 women; 4 trials; I² = 78%; Tau² = 0.14; very low-quality evidence). Heterogeneity was high for both outcomes. Duration of second stage was reported in two trials, which both showed that inflatable belts shortened duration of labour in nulliparous women (average MD -50.80 minutes, 95% CI -94.85 to -6.74 minutes; 253 women; 2 trials; I² = 97%; Tau² = 975.94; very low-quality evidence). No data on this outcome were available for multiparous women. The inflatable belt did not make any difference to rates of caesarean births (average RR 0.56, 95% CI 0.14 to 2.26; 891 women; 4 trials; I² = 70%; Tau² = 0.98), low arterial cord pH in newborn babies (RR 0.47, 95% CI 0.09 to 2.55; 461 infants; 1 trial; low-quality evidence), or Apgar scores less than seven at five minutes (RR 4.62, 95% CI 0.22 to 95.68; 500 infants; 1 trial; very low-quality evidence). Third degree perineal tears were increased in the inflatable belt group (RR 15.69, 95% CI 2.10 to 117.02; 500 women; 1 trial). Spontaneous vaginal birth within a specified time, neonatal death, andsevere maternal morbidity or death were not reported in any trial. AUTHORS' CONCLUSIONS There is insufficient evidence to draw conclusions on the beneficial or harmful effects of fundal pressure, either manually or by inflatable belt. Fundal pressure by an inflatable belt during the second stage of labour may shorten duration of second stage for nulliparous women, and lower rates of operative birth. However, existing studies are small and their generalizability is uncertain. There is insufficient evidence regarding safety for the baby. There is no evidence on the use of fundal pressure in specific clinical settings such as inability of the mother to bear down due to exhaustion or unconsciousness. There is currently insufficient evidence for the routine use of fundal pressure by any method on women in the second stage of labour. Because of current widespread use of the procedure and the potential for use in settings where other methods of assisted birth are not available, further good quality trials are needed. Further evaluation in other groups of women (such as multiparous women) will also be required. Future research should describe in detail how fundal pressure was applied and consider safety of the unborn baby, perineal outcomes, longer-term maternal and infant outcomes and maternal satisfaction.

BACKGROUND Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine. OBJECTIVES The primary objective was to assess the effects, on women and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;3. Timing of onset (early or later in labour);4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);5. Country income level (high-income compared to low- and middle-income). SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies. SELECTION CRITERIA All published and unpublished randomised controlled trials, cluster-randomised trials comparing continuous support during labour with usual care. Quasi-randomised and cross-over designs were not eligible for inclusion. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought additional information from the trial authors. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS We included a total of 27 trials, and 26 trials involving 15,858 women provided usable outcome data for analysis. These trials were conducted in 17 different countries: 13 trials were conducted in high-income settings; 13 trials in middle-income settings; and no studies in low-income settings. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (average RR 1.08, 95% confidence interval (CI) 1.04 to 1.12; 21 trials, 14,369 women; low-quality evidence) and less likely to report negative ratings of or feelings about their childbirth experience (average RR 0.69, 95% CI 0.59 to 0.79; 11 trials, 11,133 women; low-quality evidence) and to use any intrapartum analgesia (average RR 0.90, 95% CI 0.84 to 0.96; 15 trials, 12,433 women). In addition, their labours were shorter (MD -0.69 hours, 95% CI -1.04 to -0.34; 13 trials, 5429 women; low-quality evidence), they were less likely to have a caesarean birth (average RR 0.75, 95% CI 0.64 to 0.88; 24 trials, 15,347 women; low-quality evidence) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96; 19 trials, 14,118 women), regional analgesia (average RR 0.93, 95% CI 0.88 to 0.99; 9 trials, 11,444 women), or a baby with a low five-minute Apgar score (RR 0.62, 95% CI 0.46 to 0.85; 14 trials, 12,615 women). Data from two trials for postpartum depression were not combined due to differences in women, hospitals and care providers included; both trials found fewer women developed depressive symptomatology if they had been supported in birth, although this may have been a chance result in one of the studies (low-quality evidence). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, such as admission to special care nursery (average RR 0.97, 95% CI 0.76 to 1.25; 7 trials, 8897 women; low-quality evidence), and exclusive or any breastfeeding at any time point (average RR 1.05, 95% CI 0.96 to 1.16; 4 trials, 5584 women; low-quality evidence).Subgroup analyses suggested that continuous support was most effective at reducing caesarean birth, when the provider was present in a doula role, and in settings in which epidural analgesia was not routinely available. Continuous labour support in settings where women were not permitted to have companions of their choosing with them in labour, was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. Subgroup analysis of trials conducted in high-income compared with trials in middle-income countries suggests that continuous labour support offers similar benefits to women and babies for most outcomes, with the exception of caesarean birth, where studies from middle-income countries showed a larger reduction in caesarean birth. No conclusions could be drawn about low-income settings, electronic fetal monitoring, the timing of onset of continuous support or model of support.Risk of bias varied in included studies: no study clearly blinded women and personnel; only one study sufficiently blinded outcome assessors. All other domains were of varying degrees of risk of bias. The quality of evidence was downgraded for lack of blinding in studies and other limitations in study designs, inconsistency, or imprecision of effect estimates. AUTHORS' CONCLUSIONS Continuous support during labour may improve outcomes for women and infants, including increased spontaneous vaginal birth, shorter duration of labour, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional analgesia, low five-minute Apgar score and negative feelings about childbirth experiences. We found no evidence of harms of continuous labour support. Subgroup analyses should be interpreted with caution, and considered as exploratory and hypothesis-generating, but evidence suggests continuous support with certain provider characteristics, in settings where epidural analgesia was not routinely available, in settings where women were not permitted to have companions of their choosing in labour, and in middle-income country settings, may have a favourable impact on outcomes such as caesarean birth. Future research on continuous support during labour could focus on longer-term outcomes (breastfeeding, mother-infant interactions, postpartum depression, self-esteem, difficulty mothering) and include more woman-centred outcomes in low-income settings.

BackgroundFundal pressure during the second stage of labour (also known as the 'Kristellermanoeuvre') involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal, in an attempt to assist spontaneous vaginal birth and avoid prolonged second stage or the need for operative birth. Fundal pressure has also been applied using an inflatable belt. Fundal pressure is widely used, however methods of its use vary widely. Despite strongly held opinions in favour of and against the use of fundal pressure, there is limited evidence regarding its maternal and neonatal benefits and harms. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour.ObjectivesTo determine if fundal pressure is effective in achieving spontaneous vaginal birth, and preventing prolonged second stage or the need for operative birth, and to explore maternal and neonatal adverse effects related to fundal pressure.Search methodsWe searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies.Selection criteriaRandomised and quasi-randomised controlled trials of fundal pressure (manual or by inflatable belt) versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation.Data collection and analysisTwo or more review authors independently assessed potential studies for inclusion and quality. We extracted data using a pre-designed form. We entered data into Review Manager 5 software and checked for accuracy.Main resultsNine trials are included in this updated review. Five trials (3057 women) compared manual fundal pressure versus no fundal pressure. Four trials (891 women) compared fundal pressure by means of an inflatable belt versus no fundal pressure. It was not possible to blind women and staff to this intervention. We assessed two trials as being at high risk of attrition bias and another at high risk of reporting bias. All other trials were low or unclear for other risk of bias domains. Most of the trials had design limitations. Heterogeneity was high for the majority of outcomes.Manual fundal pressure versus no fundal pressureManual fundal pressure was not associated with changes in: spontaneous vaginal birth within a specified time (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.71 to 1.28; 120 women; 1 trial; very low-quality evidence), instrumental births (RR 3.28, 95% CI 0.14 to 79.65; 197 women; 1 trial), caesarean births (RR 1.10, 95% CI 0.07 to 17.27; 197 women; 1 trial), operative birth (average RR 0.66, 95% CI 0.12 to 3.55; 317 women; 2 studies; I-2 = 43%; Tau(2) = 0.71; very low-quality evidence), duration of second stage (mean difference (MD) -0.80 minutes, 95% CI -3.66 to 2.06 minutes; 194 women; 1 study; very low-quality evidence), low arterial cord pH in newborn babies (RR 1.07, 95% CI 0.72 to 1.58; 297 women; 2 trials; very low-quality evidence), or Apgar scores less than seven at five minutes (average RR 4.48, 95% CI 0.28 to 71.45; 2759 infants; 4 trials; I-2 = 89%; Tau(2) = 3.55; very low-quality evidence). More women who received manual fundal pressure had cervical tears than in the control group (RR 4.90, 95% CI 1.09 to 21.98; 295 women; 1 trial). No neonatal deaths occurred in either of the two studies reporting this outcome (very low-quality evidence). No trial reported the outcome severe maternal morbidity or death.Fundal pressure by inflatable belt versus no fundal pressureFundal pressure by inflatable belt did not reduce the number of women havinginstrumental births (average RR 0.73, 95% CI 0.52 to 1.02; 891 women; 4 trials; I-2 = 52%; Tau(2) = 0.05) or operative births (average RR 0.62, 95% CI 0.38 to 1.01; 891 women; 4 trials; I-2 = 78%; Tau(2) = 0.14; very low-quality evidence). Heterogeneity was high for both outcomes. Duration of second stage was reported in two trials, which both showed that inflatable belts shortened duration of labour in nulliparous women (averageMD -50.80 minutes, 95% CI -94.85 to -6.74 minutes; 253 women; 2 trials; I-2 = 97%; Tau(2) = 975.94; very low-quality evidence). No data on this outcome were available for multiparous women. The inflatable belt did not make any difference to rates of caesarean births (average RR 0.56, 95% CI 0.14 to 2.26; 891 women; 4 trials; I-2 = 70%; Tau(2) = 0.98), low arterial cord pH in newborn babies (RR 0.47, 95% CI 0.09 to 2.55; 461 infants; 1 trial; low-quality evidence), or Apgar scores less than seven at five minutes (RR 4.62, 95% CI 0.22 to 95.68; 500 infants; 1 trial; very low-quality evidence). Third degree perineal tears were increased in the inflatable belt group (RR 15.69, 95% CI 2.10 to 117.02; 500 women; 1 trial). Spontaneous vaginal birth within a specified time, neonatal death, andsevere maternal morbidity or death were not reported in any trial.Authors' conclusionsThere is insufficient evidence to draw conclusions on the beneficial or harmful effects of fundal pressure, either manually or by inflatable belt. Fundal pressure by an inflatable belt during the second stage of labour may shorten duration of second stage for nulliparous women, and lower rates of operative birth. However, existing studies are small and their generalizability is uncertain. There is insufficient evidence regarding safety for the baby. There is no evidence on the use of fundal pressure in specific clinical settings such as inability of the mother to bear down due to exhaustion or unconsciousness. There is currently insufficient evidence for the routine use of fundal pressure by any method on women in the second stage of labour. Because of current widespread use of the procedure and the potential for use in settings where other methods of assisted birth are not available, further good quality trials are needed. Further evaluation in other groups of women (such as multiparous women) will also be required. Future research should describe in detail how fundal pressure was applied and consider safety of the unborn baby, perineal outcomes, longer-term maternal and infant outcomes and maternal satisfaction.

BackgroundCardiotocography (known also as electronic fetal monitoring), records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic), so additional assessments of fetal wellbeing may be used, or the baby delivered by caesarean section or instrumental vaginal birth.ObjectivesTo evaluate the effectiveness of continuous cardiotocography during labour.Search methodsWe searched the Cochrane Pregnancy and Childbirth Group Trials Register (31 December 2012) and reference lists of retrieved studies.Selection criteriaRandomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with (a) no fetal monitoring, (b) intermittent auscultation (c) intermittent cardiotocography.Data collection and analysisTwo review authors independently assessed study eligibility, quality and extracted data from included studies.Main resultsThirteen trials were included with over 37,000 women; only two were judged to be of high quality.Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, n = 33,513, 11 trials), but was associated with a halving of neonatal seizures (RR 0.50, 95% CI 0.31 to 0.80, n = 32,386, nine trials). There was no significant difference in cerebral palsy rates (RR 1.75, 95% CI 0.84 to 3.63, n = 13,252, two trials). There was a significant increase in caesarean sections associated with continuous cardiotocography (RR 1.63, 95% CI 1.29 to 2.07, n = 18,861, 11 trials). Women were also more likely to have an instrumental vaginal birth (RR 1.15, 95% CI 1.01 to 1.33, n = 18,615, 10 trials).Data for subgroups of low-risk, high-risk, preterm pregnancies and high-quality trials were consistent with overall results. Access to fetal blood sampling did not appear to influence the difference in neonatal seizures nor any other prespecified outcome.Authors' conclusionsContinuous cardiotocography during labour is associated with a reduction in neonatal seizures, but no significant differences in cerebral palsy, infant mortality or other standard measures of neonatal well-being. However, continuous cardiotocography was associated with an increase in caesarean sections and instrumental vaginal births. The challenge is how best to convey these results to women to enable them to make an informed choice without compromising the normality of labour.

BACKGROUND:Parenteral opioids (intramuscular and intravenous drugs including patient-controlled analgesia) are used for pain relief in labour in many countries throughout the world. This review is an update of a review first published in 2010. OBJECTIVES:To assess the effectiveness, safety and acceptability to women of different types, doses and modes of administration of parenteral opioid analgesia in labour. A second objective is to assess the effects of opioids in labour on the baby in terms of safety, condition at birth and early feeding. SEARCH METHODS:We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (11 May 2017) and reference lists of retrieved studies. SELECTION CRITERIA:We included randomised controlled trials examining the use of intramuscular or intravenous opioids (including patient-controlled analgesia) for women in labour. Cluster-randomised trials were also eligible for inclusion, although none were identified. We did not include quasi-randomised trials. We looked at studies comparing an opioid with another opioid, placebo, no treatment, other non-pharmacological interventions (transcutaneous electrical nerve stimulation (TENS)) or inhaled analgesia. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of each evidence synthesis using the GRADE approach. MAIN RESULTS:We included 70 studies that compared an opioid with placebo or no treatment, another opioid administered intramuscularly or intravenously or compared with TENS applied to the back. Sixty-one studies involving more than 8000 women contributed data to the review and these studies reported on 34 different comparisons; for many comparisons and outcomes only one study contributed data. All of the studies were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. We excluded studies focusing on women with pre-eclampsia or pre-existing conditions or with a compromised fetus. Overall, the evidence was graded as low- or very low-quality regarding the analgesic effect of opioids and satisfaction with analgesia; evidence was downgraded because of study design limitations, and many of the studies were underpowered to detect differences between groups and so effect estimates were imprecise. Due to the large number of different comparisons, it was not possible to present GRADE findings for every comparison.For the comparison of intramuscular pethidine (50 mg/100 mg) versus placebo, no clear differences were found in maternal satisfaction with analgesia measured during labour (number of women satisfied or very satisfied after 30 minutes: 50 women; 1 trial; risk ratio (RR) 7.00, 95% confidence interval (CI) 0.38 to 128.87, very low-quality evidence), or number of women requesting an epidural (50 women; 1 trial; RR 0.50, 95% CI 0.14 to 1.78; very low-quality evidence). Pain scores (reduction in visual analogue scale (VAS) score of at least 40 mm: 50 women; 1 trial; RR 25, 95% CI 1.56 to 400, low-quality evidence) and pain measured in labour (women reporting pain relief to be "good" or "fair" within one hour of administration: 116 women; 1 trial; RR 1.75, 95% CI 1.24 to 2.47, low-quality evidence) were both reduced in the pethidine group, and fewer women requested any additional analgesia (50 women; 1 trial; RR 0.71, 95% CI 0.54 to 0.94, low-quality evidence).There was limited information on adverse effects and harm to women and babies. There were few results that clearly showed that one opioid was more effective than another. Overall, findings indicated that parenteral opioids provided some pain relief and moderate satisfaction with analgesia in labour. Opioid drugs were associated with maternal nausea, vomiting and drowsiness, although different opioid drugs were associated with different adverse effects. There was no clear evidence of adverse effects of opioids on the newborn. We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects. AUTHORS' CONCLUSIONS:Though most evidence is of low- or very-low quality, for healthy women with an uncomplicated pregnancy who are giving birth at 37 to 42 weeks, parenteral opioids appear to provide some relief from pain in labour but are associated with drowsiness, nausea, and vomiting in the woman. Effects on the newborn are unclear. Maternal satisfaction with opioid analgesia was largely unreported. The review needs to be examined alongside related Cochrane reviews. More research is needed to determine which analgesic intervention is most effective, and provides greatest satisfaction to women with acceptable adverse effects for mothers and their newborn.