Outcomes in prevention and management of miscarriage trials: a systematic review.

BACKGROUND: There is a substantial body of research evaluating ways to prevent and manage miscarriage, but all studies do not report on the same outcomes. OBJECTIVE: To review systematically, outcomes reported in existing miscarriage trials. SEARCH STRATEGY: MEDLINE, Embase, CINAHL, and Cochrane were searched from inception until January 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) reporting prevention or management of miscarriage. Miscarriage was defined as a pregnancy loss in the first trimester. DATA COLLECTION AND ANALYSIS: Data about the study characteristics, primary, and secondary outcomes were extracted. MAIN RESULTS: We retrieved 1553 titles and abstracts, from which 208 RCTs were included. For prevention of miscarriage, the most commonly reported primary outcome was live birth and the top four reported outcomes were pregnancy loss/stillbirth (n = 112), gestation of birth (n = 68), birth dimensions (n = 65), and live birth (n = 49). For these four outcomes, 58 specific measures were used for evaluation. For management of miscarriage, the most commonly reported primary outcome was efficacy of treatment. The top four reported outcomes were bleeding (n = 186), efficacy of miscarriage treatment (n = 105), infection (n = 97), and quality of life (n = 90). For these outcomes, 130 specific measures were used for evaluation. CONCLUSIONS: Our review found considerable variation in the reporting of primary and secondary outcomes along with the measures used to assess them. There is a need for standardised patient-centred clinical outcomes through the development of a core outcome set; the work from this systematic review will form the foundation of the core outcome set for miscarriage. TWEETABLE ABSTRACT: There is disparity in the reporting of outcomes and the measures used to assess them in miscarriage trials.

Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

BACKGROUND: Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients. OBJECTIVES: To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health. SEARCH STRATEGY: Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015. SELECTION CRITERIA: We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort. DATA COLLECTION AND ANALYSIS: Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression. MAIN RESULTS: There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with non-participants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I2  = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88). CONCLUSIONS: Women participating in RCTs on average experienced better outcomes compared with those outside trials. TWEETABLE ABSTRACT: Participants in obstetric and gynaecology RCTs experience better outcomes compared with non-participants.