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Q&A

Epidemiology

Poster Session 2

(535) Comparison of Obstetrical Randomized Controlled Trials That Target Maternal or Fetal/Neonatal Benefit

Tuesday, February 13, 2024

3:30 PM – 5:00 PM

Location: Prince George's Exhibit Hall CDE, Lower Atrium Level

Primary & Presenting Author(s)

Rachel Moody, BS (she/her/hers)

Medical Student
Warren Alpert Medical School of Brown University
West Warwick, RI, United States

Coauthor(s)

Anna Whelan, MD (she/her/hers)

University of Massachusetts Chan Medical School
Grafton, MA, United States
IR

Indira Ranaweera, MD

Beth Israel Deaconess Medical Center
Boston, MA, United States
Uma Deshmukh, MD

Maternal-Fetal Medicine Fellow
Beth Israel Deaconess Medical Center
Boston, MA, United States
Suneet P. Chauhan, MD

Professor
University of Texas-Houston Medical School
Houston, TX, United States
Yinka Oyelese, MD (he/him/his)

Director, Obstetric Imaging
Beth Israel Deaconess Medical Center
Boston, MA, United States
SW

Stephen M. Wagner, MD

Assistant Professor
Beth Israel Deaconess Medical Center
Brookline, MA, United States
MG

Megha Gupta, MD

Assistant Professor
Beth Israel Deaconess Medical Center
Boston, MA, United States

Objective:

Obstetrical research is often both physiologically and ethically complex. Maternal and fetal interests may diverge, particularly in the research setting. This study aimed to evaluate the characteristics of randomized controlled trials (RCTs) focused on maternal versus fetal / neonatal outcomes.

Study Design:

Obstetrical articles published in seven journals (NEJM/JAMA/Lancet, AJOG/Obstetrics & Gynecology/BJOG/AJOG MFM) from 2017-22 were analyzed. Studies were classified as investigating either maternal or fetal/neonatal benefit based on the documented primary study objective. Data was analyzed using Fisher’s test and Wilcoxon rank-sum test. P-value of < 0.05 was considered to be statistically significant.

Results: Of 248 RCTs, 191 examined solely maternal (125, 65%) or solely neonatal/fetal (66, 34.6%) outcomes in the primary objective. Interventions for fetal/neonatal benefit were more often international (80.3% vs 47.1%, p< 0.001), multi-center (68.2% vs 40.0%, p< 0.001), and published in non-obstetrical journals (39.4% vs 12.8%, p< 0.001). Fetal/Neonatal benefit trials examined preventative measures more often than treatment (75.8% vs 56.0%, p< 0.001) and occurred most commonly in the antepartum (versus intrapartum) setting (71.2% v 28.8%, p< 0.001). Studies with maternal benefit as the primary outcome were smaller (200 [90-504] vs 476 (200-1600), p< 0.001) and carried out over a shorter time period (22.3 (11.2-36.0)mo vs 36.0 (21.4-47.7)mo, p< 0.001). There was no difference between the cohorts in the type of intervention or whether the trials demonstrated a positive result.

Conclusion:

While the majority of obstetrical RCTs focused on maternal benefit as the primary outcome, fetal/neonatal oriented trials were larger and more likely to focus on prevention of disease in the antepartum period. Our results may inform investigators, and policy makers regarding trends and gaps in the obstetrical research completed over the past 5 years.