Madeline FLANAGAN

and 12 more

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality. Uterotonics are the mainstay of PPH prevention. Objectives: To compare the efficacy of misoprostol and oxytocin for the prevention of PPH, and to evaluate the trustworthiness of trials comparing these uterotonics. Search strategy and selection criteria: Seven databases were searched for peer-reviewed literature, meeting the inclusion criteria of randomized controlled trials (RCTs) comparing misoprostol and oxytocin for the prevention of PPH. Data Collection and Analysis: Data were collected by two independent reviewers. Individual participant data (IPD) was meta-analyzed for outcomes PPH≥500mL and PPH≥1000mL. RCTs that did not share IPD were classified as trustworthy or not and were included in an aggregate data meta-analysis according to trustworthiness. Main results: Of 79 eligible RCTs, ten (12.7%) provided IPD, of which six were included. Analysis of IPD showed PPH≥500mL to be significantly higher in the misoprostol than the oxytocin group (2,022 women, aOR 1.84, 95% CI 1.43- 2.34). For PPH≥1000mL, analysis of IPD showed misoprostol and oxytocin were comparable (2022 women, OR 1.14, 95% CI 0.68- 1.91). Of the 69 studies that did not provide IPD, 23 (33.3%) were assessed as trustworthy. Analysis of trustworthy data (IPD and 23 aggregate data RCTs) showed no difference between misoprostol and oxytocin for PPH≥500mL (24,334 women, OR 1.01, 95% CI 0.69- 1.49), while misoprostol significantly increased the risk for PPH≥1000 (25,249 women, OR 1.36, 95% CI 1.16- 1.59). Conclusions: Of 79 RCTs comparing misoprostol and oxytocin for the prevention of PPH, 36.7% met trustworthiness criteria. Analysis of trustworthy data suggests oxytocin is superior to misoprostol for preventing PPH.

Siddharth Shivantha

and 4 more

Objective: There are increasing concerns about the trustworthiness of the medical literature. When identified after publication, such concerns about published papers can be addressed through a post-publication review (PPR) system. We evaluated the effectiveness and efficiency of this system while addressing studies in women’s health. Design: Cohort study Setting: The project was conducted at the Department of Obstetrics and Gynaecology, Monash University, Australia. Sample: Papers Published in Women’s Health Journals Methods: We wrote to the editors and publishers about potentially untrustworthy papers in women’s health and requested an investigation according to the procedure established by the Committee of Publication Ethics (COPE). Main outcome measure: For each paper, we tabulated the trial characteristics, investigation outcome [retraction, expression of concern (EoC), correction or no wrongdoing found] and time to decision. We also report the case completion rate per journal and publisher. Results: Between 7 th November 2017 and 30 th April 2024, we wrote to editors and publishers of 891 potentially untrustworthy papers published in 206 different journals. At present, 263 (30%) of 891 papers received an outcome, with 227 (86%) labelled as problematic (152 (58%) papers retracted; 75 (29%) EoC). It took a median time of 16 months for editors and publishers to decide, with 13% of the flagged cases reaching a decision within 12 months. Conclusions: The current PPR process is inefficient and ineffective in assessing and removing untrustworthy data from the medical literature. Funding: No funding was sought for this project.