Poster Session 3
Category: Diabetes
Poster Session 3
Katherine L. Grantz, MD, MSCR
Senior Investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Bethesda, Maryland, United States
Jessica Gleason, PhD
NICHD, NIH
Bethesda, Maryland, United States
Rajeshwari L. Sundaram, PhD
Senior Investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Bethesda, Maryland, United States
.jpg "Brenna L. Hughes, MD (she/her/hers) photo")
Brenna L. Hughes, MD (she/her/hers)
Professor
Department of Obstetrics and Gynecology, Duke University School of Medicine
Duke, North Carolina, United States
Celeste Durnwald, MD (she/her/hers)
Professor, OB/GYN, Maternal Fetal Medicine
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jessica Page, MD (she/her/hers)
Department of Maternal-Fetal Medicine, Intermountain Healthcare. Department of Maternal-Fetal Medicine, University of Utah Health
Salt Lake City, Utah, United States
Alan T. Tita, MD, MPH, PhD (he/him/his)
Assoc. Dean for Global & Women’s Health; Chair & Director, Mary Heersink Inst. of Global Health
Center for Research in Women’s Health, University of Alabama at Birmingham
Birmingham, Alabama, United States
Robert M. Silver, MD
Department of Obstetrics and Gynecology, University of Utah Health
Salt Lake City, Utah, United States
George Maxwell, MD
President of Inova Women's Service Line
Inova Fairfax Medical Campus
Fairfax, Virginia, United States
Joseph R. Biggio, Jr., MD (he/him/his)
System Chair, Women's Services
Ochsner Health
New Orleans, Louisiana, United States
John M. Thorp, MD, MS
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Daniel Molina, PhD
Technical Resources International, Inc.
Bethesda, Maryland, United States
Diane Putnick, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Bethesda, Maryland, United States
Fasil Tekola-Ayele, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Bethesda, Maryland, United States
Edwina Yeung, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Bethesda, Maryland, United States
To determine the optimal time between 37-39 weeks to initiate delivery for patients with gestational diabetes mellitus (GDM) to minimize perinatal morbidity and mortality.
Study Design:
A multi-site randomized trial, using an adaptive design, recruited pregnant women with poorly controlled GDM (elevated fasting or ≥3 post-prandial blood glucoses after receiving diabetes education, large-for-gestational-age (LGA), polyhydramnios or care nonadherence). Women were enrolled from 32 weeks (w) 0 days (d) to 36w6d and randomized at 35w0d-36w6d to one of seven 3-day initiation of delivery arms between 37w0d to 39w6d (Table 1). Delivery mode was per usual obstetrical indications. Primary outcome was a composite of perinatal morbidity and mortality. The study was stopped by the DSMB due to low enrollment (target N= up to 3,450).
Results:
From 01/2023-11/2024, 2,815 women with GDM were screened, 689 (24.5%) were eligible, 145 (5.2%) enrolled and 139 randomized. Of those randomized, 51.1% initiated delivery in the assigned window; 37.4% initiated delivery before the assigned window (44.2% due to medical indication; 25.0% spontaneous labor); and 5.8% after assigned window (62.5% due to patient or provider preference) with 5.8% unknown (e.g. trial closed). There was no significant difference in primary outcome among arms in intention-to-treat (ITT) or per-protocol analyses. (Table 1) For individual primary neonatal outcomes (ITT), there was no pattern for rates of respiratory support, NICU > 1 day or birth trauma; and no other severe morbidity or death. For secondary outcomes, rates of LGA with advancing GA were 21.1%, 10.0%, 5.3%, 9.5%, 5.0%, 30.0%, 30.0%. Serious maternal morbidity was rare (Table 2). There was no pattern for delivery mode or shoulder dystocia.
Conclusion:
Among women with poorly controlled GDM, there were high rates of co-morbid conditions and medical indications for delivery prior to assigned windows. The trial provides valuable insight into delivery timing for this high-risk population, highlighting the complexities of balancing varying outcomes associated with different gestational ages.