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

Abstract

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.

Outcomes in intervention and management of multiple pregnancies trials: A systematic review

“…Our research supports this, as the outcome domains most frequently and consistently reported by trials were 'Neonatal', 'Delivery' and Survival' and these outcomes reflect the questions identified by clinicians and researchers. The lack of patient involvement has become widely recognised and the importance of engaging them in research is being increasingly acknowledged [24,[26][27][28][29]. This is vital as researchers can only be certain that interventions are being evaluated in a way that is relevant to the target population if parents' perspectives are considered [30].…”

Role of Vaginal Microbiota Dysbiosis in Gynecological Diseases and the Potential Interventions

“…Miscarriage, defined as a spontaneous pregnancy loss before the expected point, is the most prevalent pregnancy complication (Smith et al, 2019). The etiology is multifactorial and usually secondary to other disorders, such as uterine malformation, infections, chromosomal abnormalities, and hormone deficiency (progestogen) (Haas et al, 2019).…”

What is the best method for managing early miscarriage?

“…Importantly, the longer the time interval used, the higher the chance of success of expectant and medical management. Considerable variation exists in the reporting of primary and secondary outcomes in miscarriage studies along with the measures used to assess them 11…”