(534) Comparison of Obstetrical Randomized Controlled Trials During and Peri-Pregnancy

Recent attention has focused on the preconception and postpartum periods as important areas for improving perinatal outcomes. This study aimed to examine characteristics of obstetrical randomized controlled trials (RCTs) based on timing of intervention.

Study Design: All obstetrical RCTs published in seven journals (NEJM/JAMA/Lancet, AJOG/Obstetrics & Gynecology/BJOG/AJOG MFM) from 2017-22 were collected and analyzed. Studies were categorized based on the time period (antepartum/intrapartum or preconception/postpartum) that the primary intervention was applied. Data was analyzed using Fisher’s exact and Wilcoxon rank-sum test. P-value of < 0.05 was considered to be statistically significant.

Results:

Of the 247 RCTs, only 35 (14.2%) focused on preconception or postpartum time period. While the preconception and postpartum RCTs were mostly single-center studies (84.9%) in the US (70.6%), antepartum and intrapartum RCTs were more often multicenter studies (52.4%) performed in the US and other countries (56.7%p< 0.003). Preconception or postpartum studies were more likely to involve a drug intervention compared with studies performed in the ante/intrapartum period (44.1% vs 35.1%, P < 0.01). Preconception or postpartum studies were far more likely than antenatal studies to benefit the mother alone vs benefiting the fetus/newborn or both (91.2% vs 44.6%, p< 0.001).

Conclusion:

The majority of obstetrical RCTs published in the 7 journals from 2017-22 were focused on interventions in the antepartum/intrapartum period versus the preconception/postpartum period. RCTs focusing on the preconception/postpartum period are lacking, and of the published studies the majority had small sample sizes and were performed at a single institution. There is a need for more large, multi-center obstetrical RCTs with interventions in the preconception or postpartum period.