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Objective: To evaluate the long‐term outcomes of children born to women with a short cervix and otherwise low risk for preterm birth, after antenatal exposure to vaginal progesterone vs placebo. Methods: This was a follow‐up study of the Triple P trial, which randomized 80 low‐risk women with a short cervix (≤ 30 mm) at 18–22 weeks' gestation to progesterone (n = 41) or placebo (n = 39). At 2 years of corrected age, children were invited for a neurodevelopmental assessment, using the Bayley Scales of Infant and Toddler Development, third edition (BSID‐III), and a neurological and physical examination by an assessor blinded to the allocated treatment. Parents filled out the Ages and Stages Questionnaire, the Child Behavior Checklist (CBCL) and a general‐health questionnaire. The main outcome of interest was mean BSID‐III cognitive and motor scores. Additionally, a composite score of mortality and abnormal developmental outcome, including BSID‐III ≤–1 SD, CBCL score in the clinical range and/or parental reported physical problems (at least two operations or at least two hospital admissions in the previous 2 years), was evaluated. Our sample size, dictated by the original sample of the Triple P trial, provided 80% power to detect a mean difference (MD) of 15 points (1 SD) between groups for the BSID‐III tests. Results: Of the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period. Follow‐up data were obtained for 59/77 (77%) children and BSID‐III outcomes in 57 children (n = 28 in the progesterone group and n = 29 in the placebo group) born at a median gestational age of 38 + 6 weeks (interquartile range (IQR), 37 + 3 to 40 + 1 weeks) with a median birth weight of 3240 g (IQR, 2785–3620 g). In the progesterone vs placebo groups, mean BSID‐III cognitive development scores were 101.6 vs 105.0 (MD, –3.4 (95% CI, –9.3 to 2.6); P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, –4.9 (95% CI, –11.2 to 1.4); P = 0.13). No differences were seen between the two groups in physical (including genital and neurological examination), behavioral and health‐related outcomes. Conclusion: In this sample of children born to low‐risk women with a short cervix at screening, no relevant differences in neurodevelopmental, behavioral, health‐related and physical outcomes were found between offspring exposed to vaginal progesterone and those exposed to placebo. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Objective: To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.Design: The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.Methods: Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health.Main Outcome Measures: The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.Results: Of the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.Conclusion: Outcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.Tweetable Abstract: Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function and behaviour. [ABSTRACT FROM AUTHOR]

Objective: To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).Design: Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.Setting: An international web-based survey combined with a consensus development meeting.Population: Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.Methods: We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round.Main Outcome Measures: A core outcome set for research on HG.Results: Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).Conclusions: This core outcome set will help standardise outcome reporting in HG trials.Tweetable Abstract: A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence. [ABSTRACT FROM AUTHOR]

Objective: To develop a set of core outcomes to be minimally reported in trials on induction of labour.Design: Two-round Delphi survey and consensus meeting.Population: Four stakeholder groups: midwives, obstetricians, neonatologists, and women's representatives.Methods: Protocol registered with COMET (Registration Number: 695). Stakeholders rated reported outcomes for importance (1-limited to 9-critical). The median rating of each outcome was calculated. The consensus criteria to include outcomes were as follows: ≥70% participants rated outcomes as critical and <15% rated outcomes as limited importance. Outcomes that did not achieve consensus were taken to round two and, if there was still no consensus, to the final consensus meeting.Main Outcome Measures: Outcomes in trials of induction of labour.Results: Of the 159 invited participants, 54% (86/159) completed the first round, and 83% completed the second round (71/86). The core outcome set included 28 core outcomes in four domains: Short-term maternal outcomes (n = 18)-cardiorespiratory arrest, damage to internal organs, death, haemorrhage, hysterectomy, infection, intensive care admission, length of hospital stay, mode of delivery, need for more than one induction agent, oxytocin augmentation, postnatal depression, pulmonary embolus, satisfaction with care, stroke, time from induction to delivery, uterine hyperstimulation, uterine scar dehiscence/rupture; short-term offspring outcomes (n = 8)-admission to the neonatal unit, birth trauma, death, hypoxic ischaemic encephalopathy/need for therapeutic hypothermia, meconium aspiration syndrome, need for respiratory support, infection, and seizures; long-term maternal outcomes (n = 1)-operative pelvic floor repair; long-term offspring outcomes (n = 1)-disability including neurodevelopmental delay.Conclusion: Trials on induction of labour should include this core outcome set to standardise reporting.Tweetable Abstract: International multistakeholder Delphi study identifies a core outcome set for trials on induction of labour. [ABSTRACT FROM AUTHOR]

Background: Hyperemesis gravidarum (HG) is a common cause of hospital admission in early pregnancy. There is no international consensus on the definition of HG, or on outcomes that should be reported in trials. Consistency in definition and outcome reporting is important for the interpretation and synthesis of data in meta-analyses.Objective: To identify which HG definitions and outcomes are currently in use in trials.Search Strategy: We searched the following sources: (1) Cochrane Central Register of Controlled Trials, (2) Embase and (3) Medline for published trials and the WHO-ICTRP database for ongoing trials (27 October 2017).Selection Criteria: All randomised clinical trials reporting on any intervention for HG were eligible.Data Collection and Analysis: Two reviewers independently assessed trial eligibility and extracted data on HG definition and outcomes.Main Results: We included 31 published trials reporting data from 2511 women and three ongoing trials with a planned sample size of 360 participants. We identified 11 definition items. Most commonly used definition items were vomiting (34 trials) and nausea (30 trials). We identified 34 distinct outcomes. Most commonly reported outcomes were vomiting (29 trials), nausea (26 trials), need for hospital treatment (14 trials) and duration of hospital (re)admission(s) (14 trials).Conclusion: There is substantial variation of HG definition and outcome reporting in trials. This hampers meaningful aggregation of trial results in meta-analysis and implementation of evidence in guidelines. To overcome this, international consensus on a definition and a core outcome set for HG trials should be developed.Tweetable Abstract: There is a wide variation of definitions and outcomes reported in trials on hyperemesis gravidarum. [ABSTRACT FROM AUTHOR]

The article by Thornton et al. establishes with data from progestogen trials something we have always feared, i.e. the corruption of reported results through selective publication of outcomes. In their analysis, trials with a predefined primary outcome showed no effect of progesterone consistently; trials that did not report a predefined primary outcome, however, had a tendency to show more promising results. Indeed this problem is so ingrained that even prospective registration of trials has not fully addressed it. This article is protected by copyright. All rights reserved. [ABSTRACT FROM AUTHOR]

Background: Progesterone is widely used in prenatal care. However, long-term effects of prenatal progesterone treatment on child development are unclear., Objectives: To evaluate long-term outcomes in children after prenatal progesterone treatment., Search Strategy: MEDLINE, Embase and Cochrane Central Register of Controlled Trials from inception to 24 May 2020., Selection Criteria: Randomised controlled trials (RCTs) reporting outcomes in children born to women who received progesterone treatment (compared with placebo or another intervention) during any trimester in pregnancy., Data Collection and Analysis: Two authors independently selected and extracted data. We used the Cochrane Risk of Bias tool for randomised trials and Quality In Prognosis Studies., Main Results: Of 388 papers, we included seven articles based on five RCTs, comprising 4222 measurements of children aged 6 months to 8 years. All studies compared progesterone to placebo in second and/or third trimester for the prevention of preterm birth. Meta-analysis (two studies, n = 890 children) showed no difference in neurodevelopment as assessed by the Bayley-III Cognitive Composite score at 2 years between children exposed to progesterone versus placebo (Standardised Mean Difference -0.04, 95% Confidence Interval -0.26 to 0.19), I 2  = 22%. Heterogeneity prohibited additional meta-analyses. Other long-term outcomes showed no differences., Conclusions: Our systematic review comprising a multitude of developmental measurements with a broad age range did not find evidence of benefit or harm in offspring prenatally exposed to progesterone treatment for the prevention of preterm birth. We identified an urgent need for follow-up studies of prenatal progesterone administration in early pregnancy and effects in offspring beyond early childhood., Tweetable Abstract: Progesterone to prevent preterm birth: no effect on child development. Outcomes after first trimester progesterone are unclear., (© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)