BACKGROUND:Tocolytics are recommended in international guidelines as treatment for threatened preterm birth. Atosiban, an oxytocin receptor antagonist, is a registered tocolytic drug specifically indicated for the treatment of threatened preterm birth. Although tocolytics have been shown to delay birth, benefits on neonatal outcomes have not been demonstrated. In the APOSTEL 8 trial we aimed to assess superiority of tocolysis with atosiban compared with placebo in threatened preterm birth from 30 weeks and 0 days (30+0 weeks) to 33+6 weeks of gestation in improving neonatal morbidity and mortality. METHODS:This was an international, multicentre, randomised, double-blind, superiority trial conducted in 26 hospitals in the Netherlands, England, and Ireland. After written informed consent, women aged 18 years or older with a singleton or twin pregnancy with threatened preterm birth from 30+0 to 33+6 weeks of gestation were randomly assigned (stratified by centre, 1:1 ratio) to intravenous atosiban or placebo. The primary outcome was a composite of perinatal mortality (stillbirth and death until 28 days postpartum) and six severe neonatal morbidities. Analysis was by intention-to-treat. Treatment effect was estimated as relative risk (RR) with 95% CI. This trial was prospectively registered at EudraCT (2017-001007-72) and the Netherlands Trial Registry (NL-OMON54673), and is complete. FINDINGS:Between Dec 4, 2017, and July 24, 2023, a total of 755 participants were randomly assigned, of whom 752 were included in the intention-to-treat analysis (atosiban n=375, placebo n=377). The primary outcome occurred in 37 (8%) of 449 infants in the atosiban group and 40 (9%) of 435 in the placebo group (RR 0·90 [95% CI 0·58-1·40]). There were three (0·7%) and four (0·9%) infants who died, respectively (RR 0·73 [0·16-3·23]); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups, and there were no maternal deaths. INTERPRETATION:We did not demonstrate superiority of atosiban over placebo in improving neonatal outcomes as treatment for threatened preterm birth from 30+0 to 33+6 weeks of gestation. As the primary goal of tocolysis should be improvement of neonatal outcomes, our outcomes question the standardised use of atosiban as treatment for threatened preterm birth from 30+0 to 33+6 weeks of gestation. Our findings should reduce practice variation across countries and will contribute to evidence-based treatment for patients with threatened preterm birth. FUNDING:ZonMw.

(Abstracted from Lancet 2025;405:1004–1013) Worldwide, 1 in 10 pregnancies results in preterm birth. In cases of threatened preterm birth, international guidelines recommend tocolytic treatment for 48 hours to prolong pregnancy for several days.

Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality. Maternal stress during pregnancy is an established risk factor for PTB. We aimed to review the effects of stress-reducing interventions during pregnancy on PTB. Studies reporting on stress-reducing interventions during pregnancy and PTB rates in general low-risk obstetric populations were included. PTB rates, low birth weight (LBW) rates, mean gestational age and birth weight, maternal anxiety and stress, and adverse perinatal outcomes were investigated. Data were extracted using a standardized extraction form, pooled effect sizes were calculated with the random effects model. Ten studies with a total of 4.816 women were included. The interventions included Pilates, yoga, a multidisciplinary stress reduction program, combination therapy (combining mindfulness, yoga, music, baby bonding, and education), and hypnosis. The incidence of PTB was significantly lower in the intervention group (RR 0.50, 95% CI 0.35 - 0.71). The overall quality of the included studies was low, and the risk of bias was high. In conclusion, this study provides evidence supporting the potential efficacy of stress-reducing interventions in reducing the incidence of PTB in low-risk women. We propose a RCT of high quality to determine the effectiveness of stress-reducing interventions in reducing PTB risk.

BACKGROUND:Women with multiple pregnancies are at risk for maternal complications such as preterm birth. Hazardous working conditions, such as physically demanding work and long and irregular working hours, might increase the risk of preterm birth. OBJECTIVE:This study primarily aimed to determine whether certain working conditions up to 20 weeks of pregnancy increase the risk of preterm birth in multiple pregnancies. The secondary objective was to evaluate whether the working conditions of Dutch women with multiple pregnancy have been adjusted to the guidelines of the Netherlands Society of Occupational Medicine. STUDY DESIGN:We performed a prospective cohort study alongside the ProTWIN trial, a multicenter randomized controlled trial that assessed whether cervical pessaries could effectively prevent preterm birth. Women with paid work of >8 hours per week completed questionnaires concerning general health and working conditions between 16 and 20 weeks of pregnancy. Univariable and multivariable logistic regression analyses were performed to identify work-related factors associated with preterm birth (32-36 weeks' gestation) and very preterm birth (<32 weeks' gestation). We analyzed a subgroup of participants who worked for more than half of the week (>28 hours). We calculated the proportion of women who reported work-related factors not in accordance with guidelines. RESULTS:We studied 383 women, of whom 168 (44%) had been randomized to pessary, 142 (37%) to care as usual, and 73 (19%) did not participate in the randomized part of the study. After adjusting for confounding variables, working >28 hours was associated with very preterm birth (n=33; 78%) (adjusted odds ratio, 3.0; 95% confidence interval, 1.1-8.1), and irregular working times were associated with preterm birth (n=26, 17%) (adjusted odds ratio, 2.0; 95% confidence interval, 1.0-4.1) and very preterm birth (n=10; 24%) (adjusted odds ratio, 2.7; 95% confidence interval, 1.0-7.3). Within a subgroup of 213 participants working >28 hours per week, multivariable analysis showed that irregular working times (n=16; 20%) (adjusted odds ratio, 3.5; 95% confidence interval, 1.2-10.1) and no/little freedom in performance of tasks (n=23; 28%) (adjusted odds ratio, 3.0; 95% confidence interval, 1.3-7.3) were associated with preterm birth. Irregular working times (n=9; 27%) (adjusted odds ratio, 3.4; 95% confidence interval, 1.0-11.1), requiring physical strength (n=9; 27%) (adjusted odds ratio, 5.3; 95% confidence interval, 1.6-17.8), high physical workload (n=7; 21%) (adjusted odds ratio, 3.9; 95% confidence interval, 1.1-13.9), and no/little freedom in performing tasks (n=10; 30%) (adjusted odds ratio, 3.2; 95% confidence interval, 1.1-9.6) were associated with very preterm birth. Before 20 weeks of pregnancy, 224 (58.5%) women with multiple pregnancy continued to work under circumstances that were not in accordance with the guidelines. CONCLUSION:In our cohort study, nearly 60% of women with multiple pregnancy continued to work under circumstances not in accordance with the guidelines to avoid physical and job strain and long and irregular working hours. Irregular hours were associated with preterm and very preterm birth, and long hours were associated with preterm birth.

Introduction Spontaneous preterm birth (sPTB) is a major contributor to neonatal morbidity and mortality worldwide. The pathophysiology of sPTB is poorly understood, in particular among nulliparous women without apparent medical or obstetric risk factors. Therefore, we aimed to identify risk factors for sPTB in healthy nulliparous women. Material and Methods We performed a prospective cohort study. Recruitment took place from February 2014 to December 2016 in 16 community midwifery centers in the Netherlands. Eligibility criteria were: >= 18 years, no previous pregnancy >16 weeks of gestation, healthy singleton pregnancy, and antenatal booking <24 weeks of gestation. At study inclusion, participants completed a questionnaire, including details on lifestyle, work, and medical history. Cervical length was measured by vaginal ultrasound at the second-trimester anomaly scan. Detailed information concerning pregnancy and birth was collected via antenatal charts. We calculated the adjusted odds ratio (aOR) and 95% confidence intervals (CI) for various risk factors with correction for socioeconomic status (SES) using logistic regression and Firth's correction. Results We included 363 women of whom pregnancy outcomes were available in 349 (96.1%) participants. The cervical length measurement was available for 225 (62.0%) participants. sPTB occurred in 26 women (7.5%). SES was associated with sPTB (OR: 3.7, 95% CI: 1.6-8.5) in univariate analysis. First or second trimester vaginal bleeding (aOR: 3.6, 95% CI: 1.4-9.0) and urinary tract infection during pregnancy (aOR: 4.9, 95% CI: 1.7-13.9) were associated with sPTB in multivariate analysis. Conclusions This prospective cohort confirms established risk factors for sPTB in nulliparous women deemed at low risk of sPTB.

Hazardous working conditions increase the risk of adverse pregnancy outcomes. In this study, we examine adherence to legislation and guidelines aimed at improving working conditions in pregnancy. Between 2014 and 2016, we recruited a prospective cohort of low-risk nulliparous pregnant women in paid employment or self-employed in 16 community midwifery practices in The Netherlands. Participants completed two questionnaires concerning demographics, education, general health and working conditions between 10–16 and 20–24 weeks of pregnancy. We calculated the proportion of participants with work-related risk factors not in accordance with legislation and/or guidelines. Of 269 participants included, 214 (80%) completed both questionnaires. At 10–16 weeks 110 (41%) participants and at 20–24 weeks 129 (63%) participants continued to work under circumstances that did not meet recommendations. Employers provided mandated information on work adjustment to 37 (15%) participants and 96 (38%) participants received no information about the potential hazards while working with biological and chemical hazards. Participants with lower educational attainment (aOR 2.2 95%CI 1.3–3.9), or employment in healthcare (aOR 4.5, 95%CI 2.2–9.0), education/childcare and social service (aOR 2.6, 95%CI 1.1–6.0 2),, catering (aOR 3.6, 95%CI 1.1–12) and industry, construction and cleaning (aOR 3.3, 95%CI 1.1–10.3) more often continued work which did not meet recommendations. There is poor adherence to national legislation and guidelines for safe working in pregnancy in The Netherlands: 50% of the pregnant women worked under hazardous conditions. Given the impact on adverse pregnancy outcomes as well as on the public purse, action to improve compliance must be taken by all stakeholders.

AbstractBackgroundThe aim of this observational study was to examine whether the course of pregnancy and birth and accompanying outcomes among low‐risk pregnant women changed in the COVID‐19 pandemic compared to the prepandemic period.MethodsWe analyzed data from the Dutch Midwifery Case Registration System (VeCaS). Differences in the course of pregnancy and birth, and accompanying maternal and neonatal outcomes, were calculated between women pregnant during the initial months of the COVID‐19 pandemic (March 1 to August 3, 2020) and the prepandemic period (March 1–August 3, 2019). We also conducted a stratified analysis by parity.ResultsWe included 5913 low‐risk pregnant women of whom 2963 (50.1%) were pregnant during the first surge of the COVID‐19 pandemic, and 2950 (49.9%) in the prepandemic period. During the COVID‐19 pandemic, more women desired and had a home birth. More women used pain medication and fewer had an episiotomy in the COVID‐19 period than prior. Multiparous women had a higher suspected rate of fetal growth restriction during COVID; however, the actual rate of small for gestational age infants was not significantly increased. We observed no differences for onset and augmentation of labor or for mode of birth, though the rate of vaginal births increased.ConclusionsDuring the COVID‐19 pandemic, there was a higher rate of planned and actual home birth, and suspected growth restriction and a lower rate of episiotomy among low‐risk pregnant women in the Netherlands.

OBJECTIVE:Work-related activities can be a risk factor for pregnancy complications such as preterm birth. This study evaluates the effectiveness of a blended care programme, Pregnancy and Work, that provides pregnant workers and their obstetrical caregivers with advice on work adjustment.METHODS:Women less than 20 weeks of gestation, in paid employment or self-employed, in the care of four participating hospitals and their referring midwifery practices in the Netherlands received either the blended care programme (n=119), consisting of a training for professionals and a mobile health application, or care as usual (n=122) in a controlled intervention study with a follow-up in intervention and control populations. All participants completed three questionnaires concerning health and working conditions at 16, 24 and 32 weeks of pregnancy. Primary outcome was the percentage of women who received advice from their obstetrical caregiver about work adjustment. Secondary outcomes were work status, realised work adjustment and working conditions. Groups were compared using univariate and multivariate regression analyses.RESULTS:A total of 188 (78%) completed all three questionnaires. In the blended care group, women received more advice from obstetrical caregivers to adjust their work than in the control group, 41 (39%) vs 21 (18%) (adjusted relative risk (aRR) 2.2, 95% CI 1.4 to 3.4), but less from their employer 8 (8%) vs 31 (28%) (aRR 0.29, 95% CI 0.14 to 0.61). There were no significant differences in realised work adjustments. At 24 weeks, 30% of the pregnant women in both groups continued to work in hazardous workplaces.CONCLUSION:Among working pregnant women, the blended care intervention increases advice on work adjustment given by midwives and obstetricians, but does not lead to more work adjustments.

METHODS: In a multicenter open-label randomized controlled trial, a cervical pessary was compared with no intervention (control group) (one-to-one ratio). Women between 24 and 34 weeks of gestation at high risk for preterm birth based on a short cervical length (less than 15 mm) or an intermediate cervical length (between 15 and 30 mm) with a positive fetal fibronectin test who did not deliver after an episode of threatened preterm labor were eligible. The primary outcome was birth before 37 weeks of gestation. Secondary outcomes were a composite adverse neonatal outcome, preterm birth before 34 and 32 weeks of gestation, and side effects. A total sample size of 200 women carrying singletons was planned so as to have adequate statistical power to detect a reduction in the rate of preterm birth from 40% to 20%. Women with twin gestations were also enrolled but were considered only in secondary analyses. After a planned interim analysis, the trial was stopped for futility.

Objective To assess the association between preterm birth and cervical length after arrested preterm labor in high-risk pregnant women. Methods In this post-hoc analysis of a randomized clinical trial, transvaginal cervical length was measured in women whose contractions had ceased 48 h after admission for threatened preterm labor. At admission, women were defined as having a high risk of preterm birth based on a cervical length of < 15 mm or a cervical length of 15-30 mm with a positive fetal fibronectin test. Logistic regression analysis was used to investigate the association of cervical length measured at least 48 h after admission and of the change in cervical length between admission and at least 48 h later, with preterm birth before 34 weeks' gestation and delivery within 7 days after admission. Results A total of 164 women were included in the analysis. Women whose cervical length increased between admission for threatened preterm labor and 48 h later (32%; n=53) were found to have a lower risk of preterm birth before 34weeks compared with women whose cervical length did not change (adjusted odds ratio (aOR), 0.24 (95% CI, 0.09-0.69)). The risk in women with a decrease in cervical length between the two time points was not different from that in women with no change in cervical length (aOR, 1.45 (95% CI, 0.62-3.41)). Moreover, greater absolute cervical length after 48 h was associated with a lower risk of preterm birth before 34 weeks (aOR, 0.90 (95% CI, 0.84-0.96)) and delivery within 7 days after admission (aOR, 0.91 (95% CI, 0.82-1.02)). Sensitivity analysis in women randomized to receive no intervention showed comparable results. Conclusion Our study suggests that the risk of preterm birth before 34weeks is lower in women whose cervical length increases between admission for threatened preterm labor and at least 48 h later when contractions had ceased compared with women in whom cervical length does not change or decreases. (C) 2021 The Authors.

Objective To study the impact of fetal gender on the risk of spontaneous preterm birth in various ethnicities. Study design National cohort study in which all singleton live births from 25(+0) weeks onwards without congenital anomalies were included of African, Asian, and Mediterranean women (1999-2010). Our primary outcome measure was preterm birth before 37 weeks. Per ethnic group, male and female neonates were compared. Result In each ethnic group, male fetuses were at increased risk of preterm birth (adjusted odds ratio (aOR) 1.63 for African, aOR 1.71 for Asian, and aOR 1.84 for Mediterranean males). The population-attributable risk of male gender on spontaneous preterm birth is lower in African women (3.9%) than in Asian (10.3%) and Mediterranean women (9.0%). Conclusion Male fetal gender is associated with spontaneous preterm birth in African, Asian, and Mediterranean women, but the total impact of ethnicity on spontaneous preterm birth rate is different.

To assess the cost‐effectiveness of treatment with nifedipine compared with atosiban in women with threatened preterm birth.

Objective: To determine the association between increasing volumes of crystalloids and colloids administered before transfusion of packed red blood cells in women with persistent postpartum haemorrhage and adverse maternal outcomes. Study design: Retrospective cohort study in the Netherlands. Women with persistent postpartum haemorrhage and known clear fluids volume for resuscitation were included. Women who received <= 2 L of clear fluids were the reference group. We determined the effect of every additional litre of clear fluids on total blood loss, severe maternal morbidity and mortality. Results were adjusted for patient and bleeding characteristics. Results: Of the 883 included women, 199 received <= 2 L of clear fluids. Median blood loss for the reference group was 2.9 L (interquartile range 2.2-3.4). Adjusted mean difference in blood loss compared with the reference group was 0.2 L (95% confidence interval-0.1 to 0.5) for women in the >2 to <= 3 L, 0.4 L (0.1-0.7) for the >3 to <= 4 L category, 0.6 L (0.5-0.7) for the >4 to <= 5 L category, and 1.9 L (1.5-2.3) for the >5 to <= 7 L category. Adjusted odds ratios for adverse maternal outcomes were 1.0 (0.7-1.6), 1.2 (0.8-1.9), 1.8 (1.1-3.1) and 4.4 (2.6-7.5) for women in the 2 to <= 3 L category, >3 to <= 4L, >4 to <= 5 L, and >5 to <= 7 L volume categories respectively. Results were similar in strata of different severities of bleeding. Conclusion: Clear fluids volume >4 L was independently associated with adverse maternal outcome in women with persistent postpartum haemorrhage. (C) 2019 Elsevier B.V. All rights reserved.

BACKGROUND Pregnant women are often unaware of the potential risks that working conditions can cause to them and their unborn child. A mobile health (mHealth) app, the Pregnancy and Work (P and W) app, developed by a multidisciplinary team and based on an evidence-based guideline for occupational physicians, aims to provide advice on work adjustment during pregnancy. OBJECTIVE This study evaluates the usability of the mHealth P and W app and the perceived usefulness of the work advice, the main goal of the app, by potential end users. METHODS A total of 12 working pregnant women participated in think aloud usability sessions and performed 9 tasks. All think aloud sessions were recorded, transcribed, and coanalyzed. The usability problems were rated for their severity in accordance with Nielsen severity scale. The completion rates and time taken for completion of tasks were registered. In addition, participants were questioned on demographics and user characteristics and were asked to evaluate the value of the app by filling in the Intrinsic Motivation Inventory (IMI) score and the System Usability Scale (SUS) questionnaire. RESULTS In total, 82 usability problems with a severity ≥1 were identified, of which 40 had severity ≥3. The main usability problems concerned the interpretation of terminology used in the app’s questionnaires and difficulties in finding and understanding the work advice. Furthermore, 10 out of 12 participants were able to open the work advice page in the app. Only 7 out of these 10 participants understood and intended to follow the work advice. The overall mean IMI score was relatively high (5 out of 7), indicating that the participants did indeed value the use of the app. This IMI score corresponded to the overall mean SUS score (68 out of 100) and the mean grade given to the P and W app (7 out of 10). CONCLUSIONS This think aloud usability study showed that the information provided in the P and W app was considered valuable by the end users, working pregnant women, and it meets their needs; however, usability issues severely impacted the perceived usefulness of the work advice given in the app.

IntroductionPreterm birth complicates >15 million pregnancies annually worldwide. In many countries, women who present with signs of preterm labour are treated with tocolytics for 48 hours. Although this delays birth, it has never been shown to improve neonatal outcome. In 2015, the WHO stated that the use of tocolytics should be reconsidered and that large placebo-controlled studies to evaluate the effectiveness of tocolytics are urgently needed.Methods and analysisWe designed an international, multicentre, randomised, double-blinded, placebo-controlled clinical trial. Women with threatened preterm birth (gestational age 30–34 weeks), defined as uterine contractions with (1) a cervical length of < 15 mm or (2) a cervical length of 15–30 mm and a positive fibronectin test or (3) in centres where cervical length measurement is not part of the local protocol: a positive fibronectin test or insulin-like growth factor binding protein-1 (Actim-Partus test) or (4) ruptured membranes, will be randomly allocated to treatment with atosiban or placebo for 48 hours. The primary outcome is a composite of perinatal mortality and severe neonatal morbidity. Analysis will be by intention to treat. A sample size of 760 participants (380 per group) will detect a reduction in adverse neonatal outcome from 11.95% to 6% (alpha error 0.05, beta error 0.2). A cost-effectiveness analysis will be performed from a societal perspective.Ethics and disseminationThis study has been approved by the Research Ethics Committee (REC) of the Amsterdam University Medical Centres, location AMC, as well as the REC’s in Dublin and the UK. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.Trial registration numberNederlands Trial Register (Trial NL6469).

There is a paucity of evidence regarding long-term outcomes Background: of late preterm (34-36 weeks) and early term (37-38 weeks) delivery. The objective of this systematic review was to assess long-term cognitive outcomes of children born at these gestations. Four electronic databases (Medline, Embase, clinicaltrials.gov Methods: and PsycINFO) were searched. Last search was 5 August 2016. Studies were included if they reported gestational age, IQ measure and the ages assessed. The protocol was registered with the International prospective register of systematic reviews (PROSPERO Record ). CRD42015015472 Two independent reviewers assessed the studies. Data were abstracted and critical appraisal performed of eligible papers. Of 11,905 potential articles, seven studies reporting on 41,344 Results: children were included. For early term births, four studies (n = 35,711) consistently showed an increase in cognitive scores for infants born at full term (39-41 weeks) compared to those born at early term (37-38 weeks) with increases for each week of term (difference between 37 and 40 weeks of around 3 IQ points), despite differences in age of testing and method of IQ/cognitive testing. Four studies (n = 5644) reporting childhood cognitive outcomes of late preterm births (34 – 36 weeks) also differed in study design (cohort and case control); age of testing; and method of IQ testing, and found no differences in outcomes between late preterm and term births, although risk of bias was high in included studies. Children born at 39-41 weeks have higher cognitive outcome Conclusion: scores compared to those born at early term (37-38 weeks). This should be considered when discussing timing of delivery. For children born late preterm, the data is scarce and when compared to full term (37-42 weeks) did not show any difference in IQ scores.

Objective: Studies on the optimal mode of delivery in women with a twin pregnancy Study Design: Population-based cohort study including all women with twin pregnancy who delivered very preterm (26-32 weeks of gestation) in the Netherlands between January 2000 and December 2010. We compared perinatal mortality and neonatal and maternal morbidity according to the intended mode of delivery as well as to the actual mode of delivery. Perinatal outcomes were paired taking into account the dependency between the children of the same twin pregnancy and were also analysed for each child separately. We used logistic regression to correct for possible confounding factors. Results: We studied 1,655 women with a very preterm delivery of a twin pregnancy. A planned caesarean section (n = 212) was associated with a significantly higher perinatal mortality compared to a planned vaginal delivery (n = 1.443) (10% compared to 6.5%; adjusted odds ratio (OR) 2.5, 95% confidence interval (CI) 1.5-4.2). The same applied for perinatal morbidity (66% compared to 63%; adjusted OR 1.5, 95% CI 1.1-2.0), maternal morbidity (17% compared to 4.9%; adjusted OR 4.0, 95% CI 2.6-6.3) and for perinatal mortality for the second twin (7.1% compared to 3.5% adjusted OR 2.9, 95% CI 1.7-5.2). Conclusion: In very preterm delivery of twins a vaginal delivery is the preferred mode of delivery.

IMPORTANCE Early plasma transfusion for women with severe postpartum hemorrhage (PPH) is recommended to prevent coagulopathy. However, there is no comparative, quantitative evidence on the association of early plasma transfusion with maternal outcomes. OBJECTIVE To compare the incidence of adverse maternal outcomes among women who received plasma during the first 60 minutes of persistent PPH vs women who did not receive plasma for similarly severe persistent PPH. DESIGN, SETTING, AND PARTICIPANTS This multicenter cohort study used a consecutive sample of women with persistent PPH, defined as PPH refractory to first-line measures to control bleeding, between January 1, 2011, and January 1, 2013. Time-dependent propensity score matching was used to select women who received plasma during the first 60 minutes of persistent PPH and match each of them with a woman who had shown the same severity and received the same treatment of PPH but who had not received plasma at the moment of matching. Transfusions were not guided by coagulation tests. Statistical analysis was performed from June 2018 to June 2019. EXPOSURES Transfusion of plasma during the first 60 minutes of persistent PPH vs no or later plasma transfusion. MAIN OUTCOMES AND MEASURES Incidence of adverse maternal outcomes, defined as a composite of death, hysterectomy, or arterial embolization. RESULTS This study included 1216 women (mean [SD] age, 31.6 [5.0] years) with persistent PPH, of whom 932 (76.6%) delivered vaginally and 780 (64.1%) had PPH caused by uterine atony. Seven women (0.6%) died because of PPH, 62 women (5.1%) had a hysterectomy, and 159 women (13.1%) had arterial embolizations. Among women who received plasma during the first 60 minutes of persistent PPH, 114 women could be matched with a comparable woman who had not received plasma at the moment of matching. The incidence of adverse maternal outcomes was similar between the women, with adverse outcomes recorded in 24 women (21.2%) who received early plasma transfusion and 23 women (19.9%) who did not receive early plasma transfusion (odds ratio, 1.09; 95% CI, 0.57-2.09). Results of sensitivity analyses were comparable to the primary results. CONCLUSIONS AND RELEVANCE In this cohort study, initiation of plasma transfusion during the first 60 minutes of persistent PPH was not associated with adverse maternal outcomes compared with no or later plasma transfusion, independent of severity of PPH.

AIM:Diabetes is associated with a high risk of adverse pregnancy outcomes. Optimal glycaemic control is fundamental and is traditionally monitored with self-measured glucose profiles and periodic HbA1c measurements. We investigated the effectiveness of additional use of retrospective continuous glucose monitoring (CGM) in diabetic pregnancies. MATERIAL AND METHODS:We performed a nationwide multicentre, open label, randomized, controlled trial to study pregnant women with type 1 or type 2 diabetes who were undergoing insulin therapy at gestational age < 16 weeks, or women who were undergoing insulin treatment for gestational diabetes at gestational age < 30 weeks. Women were randomly allocated (1:1) to intermittent use of retrospective CGM or to standard treatment. Glycaemic control was assessed by CGM for 5-7 days every 6 weeks in the CGM group, while self-monitoring of blood glucose and HbA1c measurements were applied in both groups. Primary outcome was macrosomia, defined as birth weight above the 90th percentile. Secondary outcomes were glycaemic control and maternal and neonatal complications. RESULTS:Between July 2011 and September 2015, we randomized 300 pregnant women with type 1 (n = 109), type 2 (n = 82) or with gestational (n = 109) diabetes to either CGM (n = 147) or standard treatment (n = 153). The incidence of macrosomia was 31.0% in the CGM group and 28.4% in the standard treatment group (relative risk [RR], 1.06; 95% CI, 0.83-1.37). HbA1c levels were similar between treatment groups. CONCLUSIONS:In diabetic pregnancy, use of intermittent retrospective CGM did not reduce the risk of macrosomia. CGM provides detailed information concerning glycaemic fluctuations but, as a treatment strategy, does not translate into improved pregnancy outcome.