Progesterone for Neurodevelopment in Fetuses With Congenital Heart Defects

作者：J. William Gaynor, Julie S. Moldenhauer, Erin Zullo, Nancy Burnham, Marsha Gerdes, Judy Bernbaum, Jo Ann D’Agostino, Rebecca L. Linn, Brenna Klepczynski, Isabel Randazzo, Gabrielle Gionet, Grace Choi, Antoneta Karaj, William Russell, Elaine H. Zackai, Mark P. Johnson, Juliana Gebb, Shelly Soni, Suzanne E. DeBari, Anita Szwast, Rebecca C. Ahrens‐Nicklas, Theodore G. Drivas, Marin Jacobwitz, Daniel J. Licht, Arastoo Vossough, Susan C. Nicolson, Thomas L. Spray, Jack Rychik, Mary Putt · 发表于：JAMA Network Open · 年份：2024 · DOI：10.1001/jamanetworkopen.2024.12291 · 被引用次数：13 · 研究领域：Congenital Heart Disease Studies、Congenital heart defects research、Cardiovascular Issues in Pregnancy

Importance: Neurodevelopmental outcomes for children with congenital heart defects (CHD) have improved minimally over the past 20 years. Objectives: To assess the feasibility and tolerability of maternal progesterone therapy as well as the magnitude of the effect on neurodevelopment for fetuses with CHD. Design, Setting, and Participants: This double-blinded individually randomized parallel-group clinical trial of vaginal natural progesterone therapy vs placebo in participants carrying fetuses with CHD was conducted between July 2014 and November 2021 at a quaternary care children's hospital. Participants included maternal-fetal dyads where the fetus had CHD identified before 28 weeks' gestational age and was likely to need surgery with cardiopulmonary bypass in the neonatal period. Exclusion criteria included a major genetic or extracardiac anomaly other than 22q11 deletion syndrome and known contraindication to progesterone. Statistical analysis was performed June 2022 to April 2024. Intervention: Participants were 1:1 block-randomized to vaginal progesterone or placebo by diagnosis: hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA), and other CHD diagnoses. Treatment was administered twice daily between 28 and up to 39 weeks' gestational age. Main Outcomes and Measures: The primary outcome was the motor score of the Bayley Scales of Infant and Toddler Development-III; secondary outcomes included language and cognitive scales. Exploratory pre...