Child outcomes after placement of a cervical pessary in women with a multiple pregnancy : A 4-year follow-up of the ProTWIN trial

Acknowledgements We like to thank the research nurses of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology for their help in finding contact details of the parents.Peer reviewedPublisher PD

Variation in hyperemesis gravidarum definition and outcome reporting in randomised clinical trials: a systematic review

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

A core outcome set for hyperemesis gravidarum research: an international consensus study

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