Randomized controlled trials (RCTs) on using a cervical pessary after an episode of preterm labor (PTL) show contradictive results. This study aims to perform an Individual Participant Data Meta-Analysis (IPD-MA) to assess the effectiveness of a cervical pessary to prolong pregnancy after an episode of PTL. For this IPD-MA, RCTs were included that randomized pregnant women with a singleton pregnancy between 24-34 weeks with an ceased episode of PTL between cervical pessary or control (no intervention). This IPD-MA followed the PRISMA-IPD guidelines. Co-primary outcomes were: interval between randomization and delivery, delivery < 7 days and a composite of neonatal outcomes (mortality and severe morbidity). Secondary outcomes were maternal and neonatal outcomes according to the core outcomes set for preterm birth(PTB) studies. For all outcomes, a one-step meta-analysis approach was employed. Five RCTs were eligible for inclusion of which three were included(n=273 pessary group, n=268 control group). Two trials were excluded since no data was provided. Mean prolongation of pregnancy was 59.3±27.7 days for pessary compared to 54.9±27.1 days for controls with a mean difference of 4.5 days (95% CI -0.08 - 9.0; P-value 0.054). Cervical pessary did not reduce risk of delivery < 7 days (RR 0.87; 95% CI 0.40 - 1.9; P-value 0.31). Moreover, there was no reduction in composite neonatal outcome (7.7% versus 8.2%, RR 0.95; 95% CI 0.53 - 1.7). Readmissions for PTL were lower in the pessary group (45 vs. 77, RR 0.50; 95% CI 0.32-0.77). No differences were found for other secondary maternal or perinatal outcomes (Table 1). In women who went through an episode of PTL, we found no statistical significant beneficial effect for pessary placement in terms of delivery < 7 days, prolongation of pregnancy, PTB, or neonatal outcomes between both groups. Pessary reduced the probability of readmissions for PTL.

Background: A prior study suggested that implementing a cut-off value of <30 mm for a short cervical length (CL) could potentially introduce selection bias and alter the distribution of CL measurements. As such, the objective of this study is to evaluate how CL distribution and incidence of short CL are affected when using different cut-off values for a short CL. Study design: This is a secondary analysis of the Quadruple P (QP) Screening study; a prospective cohort study that included low-risk patients with singleton pregnancies undergoing fetal anomaly scan at 18-22 weeks of gestation, including a CL measurement. Patients with a short cervix, defined as <35 mm, were subsequently counseled for the QP trial; a randomized controlled trial (RCT) comparing progesterone to cervical pessary for the prevention of preterm birth. If participation to the RCT was refused, patients with a CL <25 mm were advised to use progestogen. The primary objective of this current study was to assess the normal distribution of CL across the entire cohort and to assess the incidence of short CL when using the cut-off values of <35 and <25 mm. Normal distributions for CL were simulated based on mean and standard deviation(SD) of the original data. The Kolmogorov-Smirnov test was used to evaluate the distribution of the CL measurements. Moreover, to evaluate the motives behind ultrasound measurements around the cut-off value, sonographers were asked to fill out a qualitative questionnaire. Results: The total cohort included 19.171 eligible participants who underwent CL measurement, with a mean CL of 43.9 mm (+8.1 SD). The distribution of all CL observed measurements deviated significantly from the normal distribution (p < 0.001). A total of 1.852 (9.7%) patients had short CL <35 mm, which was significantly lower than expected when compared to the simulated normal distribution (n = 2.661, 13.9%; p < 0.001). The incidence of short CL <25 mm in our cohort statistically differed from the simulated normal distribution (238, 1.2% vs 177, 0.9%; p=0.003). When comparing our data to the simulated normal distribution, the difference in distributions is most pronounced when examining the difference between 35 and 36 mm. Results of the questionnaire reveal sonographers claimed not to be influenced by a cut-off value for study participation or progesterone treatment. Conclusion: This study demonstrates that using any cut-off value for a short CL influences the incidence and distribution of CL. When using a cut-off value of <35 mm for study inclusion, the incidence of measurements of a short CL is lower than the anticipated incidence compared to a normal distribution. However, when using a cutoff value of <25 mm for progesterone treatment, the frequency of CL measurements is higher than expected below this threshold compared to a normal distribution. This study highlights the risk of introducing selection bias, most likely unintentionally, when cut-off values for short CL are used, regardless of the specific value chosen. Therefore healthcare providers should measure the CL with caution if essential decisions depend on a specific cut-off value.

OBJECTIVE: Given that many studies report on a limited spectrum of adverse events of transvaginal cervical cerclage for preventing preterm birth, but are not powered to draw conclusions about its safety, the objective of this study was to conduct a systematic review with pooled risk analyses of perioperative complications and compare characteristics on the basis of indication for cerclage in singleton pregnancies. DATA SOURCES: Ovid MEDLINE, Ovid Embase, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and the prospective trial registers ClinicalTrials. gov and the World Health Organization International Clinical Trials Registry Platform were searched from inception to April 2020. STUDY ELIGIBILITY CRITERIA: All randomized controlled trials and both retrospective and prospective observational cohort studies reporting about complications in history-indicated cerclage, ultrasound-indicated cerclage, or physical examination-indicated cerclage were eligible. Studies were included if they contained original data on the occurrence of adverse events during surgery or within 24 hours after surgery. METHODS: The Cochrane risk of bias tool for randomized controlled trials and the Newcastle-Ottawa scale for cohort and case-control studies were used for the critical appraisal. The pooled risk assessment was conducted using meta and metafor packages in R (studio), version 4.0.3. RESULTS: The search yielded 2328 potential studies; 3 randomized controlled trials, 3 prospective, and 38 retrospective cohort studies were included in the final analysis. Of the 4511 women with singleton gestations, 1561 (34.6%) underwent history-indicated cerclage, 1348 (29.9%) underwent ultrasound-indicated cerclage, and 1549 (33.3%) underwent physical examination-indicated cerclage. Most perioperative complications occurred in physical examination-indicated cerclage, especially hemorrhage (2.3%; 95% confidence interval, 0.0-7.6) and preterm premature rupture of membranes (2.5%; 95% confidence interval, 0.91-4.5). The fewest complications occurred in history-indicated cerclage, varying from 0.0% of preterm premature rupture of membranes (95% confidence interval, 0.0-1.7) to 0.9% of hemorrhage (95% confidence interval, 0.0-7.9). In ultrasound-indicated cerclage, the most common complication was hemorrhage (1.4%; 95% confidence interval, 0.0-4.1), followed by lacerations (0.6%; 95% confidence interval, 0.0-3.1) and preterm premature rupture of membranes (0.3%; 95% confidence interval, 0.0-0.8). CONCLUSION: The highest risk of perioperative complications was observed in physical examination-indicated cerclage in comparison with ultrasound- and history-indicated cerclage. However, the occurrence of complications is poorly documented in the published literature, as is the timing of the complications (ie, perioperative or later in pregnancy). There is an urgent need for uniform complication reporting policy in both cohort studies and randomized controlled trials on cerclage.

Introduction Preterm birth (PTB) is among the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is key to enable obstetric healthcare professionals to apply interventions that improve perinatal and childhood outcomes. Serial transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB and identify those at high risk for a recurrent PTB. Cervical length measurement, fetal fibronectin test or a combination of both can be used to identify women at high risk of PTB presenting with symptoms of threatened PTB. The predictive capacity of these methods can be improved. Cervical softening is a precursor of cervical shortening, effacement and dilatation and could be a new marker to identify women a high risk of PTB. However, the predictive value of cervical softening to predict spontaneous PTB still needs to be determined.Methods and analysis This is a single-centre, prospective cohort study, conducted at the Amsterdam University Medical Centers in the Netherlands. Cervical softening will be investigated with a non-invasive CE-marked device called the Pregnolia System. This device has been developed to evaluate consistency of the cervix based on tissue elasticity. Two different cohorts will be investigated. The first cohort includes women with a history of spontaneous PTB <34 weeks. These women undergo biweekly measurements between 14 and 24 weeks of gestation. The second cohort includes women with symptoms of threatened PTB. These women will receive the measurement once at presentation between 24 and 34 weeks of gestation. The primary outcome is spontaneous PTB before 34 weeks for women with a history of PTB and delivery within 7 days for women with threatened PTB. The minimum sample size required to analyse the primary outcome is 227 women in the cohort of women with a history of PTB and 163 women in the cohort of women with symptoms of threatened PTB. Once this number is achieved, the study will be continued to investigate secondary objectives.Ethics and dissemination The study is approved by the Medical Ethics Committee of Amsterdam UMC (METC2022.0226). All patients will give oral and written informed consent prior to study entry. Results will be disseminated via a peer-reviewed journal.Trial registration number NCT05477381.

Background: Evidence for progestogen maintenance therapy after an episode of preterm labour (PTL) is contradictory.Objectives: To assess effectiveness of progestogen maintenance therapy after an episode of PTL.Search Strategy: An electronic search in Central Cochrane, Ovid Embase, Ovid Medline and clinical trial databases was performed.Selection Criteria: Randomised controlled trials (RCT) investigating women between 16(+0) and 37(+0) weeks of gestation with an episode of PTL who were treated with progestogen maintenance therapy compared with a control group.Data Collection and Analysis: Systematic review and meta-analysis were conducted. The primary outcome was latency time in days. Secondary neonatal and maternal outcomes are consistent with the core outcome set for preterm birth studies. Studies were extensively assessed for data trustworthiness (integrity) and risk of bias.Main Results: Thirteen RCT (1722 women) were included. Progestogen maintenance therapy demonstrated a longer latency time of 4.32 days compared with controls (mean difference [MD] 4.32, 95% CI 0.40-8.24) and neonates were born with a higher birthweight (MD 124.25 g, 95% CI 8.99-239.51). No differences were found for other perinatal outcomes. However, when analysing studies with low risk of bias only (five RCT, 591 women), a significantly longer latency time could not be shown (MD 2.44 days; 95% CI -4.55 to 9.42).Conclusions: Progestogen maintenance therapy after PTL might have a modest effect on prolongation of latency time. When analysing low risk of bias studies only, this effect was not demonstrated. Validation through further research, preferably by an individual patient data meta-analysis is highly recommended.

Introduction: Midtrimester prelabor rupture of membranes (PROM) between 16 and 24 weeks of gestational age is a major obstetric complication with high rates of perinatal morbidity and mortality. Amnioinfusion has been proposed in women with midtrimester PROM to target oligohydramnios and subsequently enhance pulmonary development and perinatal outcomes. Material and Methods: The purpose of this study was to perform a systematic review and meta-analysis including all randomized clinical trials investigating amnioinfusion versus no intervention in women with PROM between 16+0 and 24+0 weeks of gestational age. Databases Central, Embase, Medline, ClinicalTrials.gov and references of identified articles were searched from inception of database to December 2021. The primary outcome was perinatal mortality. Secondary outcomes included neonatal, maternal, and long-term developmental outcomes as defined in the core outcome set for preterm birth studies. Summary measures were reported as pooled relative risk (RR) or mean difference with corresponding 95% confidence interval (CI). Results: Two studies (112 patients, 56 in the amnioinfusion group and 56 in the no intervention group) were included in this review. Pooled perinatal mortality was 66.1% (37/56) in the amnioinfusion group compared with 71.4% (40/56) in no intervention group (RR 0.92, 95% CI: 0.72–1.19). Other neonatal and maternal core outcomes were similar in both groups, although due to the relatively small number of events and wide CIs, there is a possibility that amnioinfusion can be associated with clinically important benefits and harms. Long-term healthy survival was seen in 35.7% (10/28) of children assessed for follow-up and treated with amnioinfusion versus 28.6% (8/28) after no intervention (RR 1.30, 95% CI: 0.47–3.60, “best case scenario”). Conclusions: Based on these findings, the benefits of amnioinfusion for midtrimester PROM <24 weeks of gestational age are unproven, and the potential harms remain undetermined.

BACKGROUND:The perforation of the device through the myometrium of the uterus is a well-known complication after the placement of an intra-uterine device (IUD). A laparoscopy is often performed to remove the IUD. The omentum or the recto-uterine pouch, also known as the pouch of Douglas, are the most likely locations of the IUD when this is dislocated.CASE DESCRIPTION:This case reports describes the case of a 36-year-old woman, where three months after giving birth an IUD was placed and the uterine wall was perforated. The patient came to the outpatient clinic because of an unwanted pregnancy. The IUD was eventually laparoscopic found in the retropubic space, the cavum Retzii CONCLUSION: After placement of an IUD, especially placed after the first months of giving birth, additional examination is recommended to check the placement. Besides the pouch of Douglas and the omentum, the IUD can be dislocated in the cavum Retzii.