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Progesterone for Neurodevelopment in Fetuses With Congenital Heart Defects: A Randomized Clinical Trial.

J William Gaynor¹, Julie S Moldenhauer², Erin E Zullo¹

¹Division of Cardiothoracic Surgery, Department of Surgery, Children's Hospital of Philadelphia, and the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

JAMA Network Open

|May 28, 2024

Summary

Maternal progesterone therapy did not improve neurodevelopmental outcomes in fetuses with congenital heart defects (CHD). However, subgroup analyses indicated potential benefits based on specific cardiac diagnoses and fetal sex.

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Area of Science:

Pediatric Cardiology
Neurodevelopmental Pediatrics
Maternal-Fetal Medicine

Background:

Children with congenital heart defects (CHD) exhibit suboptimal neurodevelopmental outcomes, with minimal improvement over two decades.
Maternal interventions during pregnancy are being explored to mitigate these deficits.

Purpose of the Study:

To evaluate the feasibility and tolerability of maternal progesterone therapy in pregnant individuals carrying fetuses with CHD.
To determine the impact of maternal progesterone on fetal neurodevelopmental outcomes in the context of CHD.

Main Methods:

A double-blinded, randomized clinical trial involving maternal-fetal dyads with fetuses diagnosed with CHD before 28 weeks' gestation.
Participants received either vaginal natural progesterone or placebo from 28 weeks' gestation until delivery.
The primary outcome was the motor score assessed using the Bayley Scales of Infant and Toddler Development-III.

Main Results:

No statistically significant difference in the primary motor score was observed between the progesterone and placebo groups (P=.34).
Exploratory analyses revealed significant heterogeneity in motor score response based on cardiac diagnosis (P for interaction=.03) and fetal sex (P for interaction=.04).
The study enrolled 102 fetuses, predominantly with hypoplastic left heart syndrome (HLHS) and transposition of the great arteries (TGA).

Conclusions:

Maternal progesterone therapy did not demonstrate an overall statistically significant effect on fetal neurodevelopmental outcomes in this cohort.
Heterogeneity in treatment response suggests that progesterone may have differential effects depending on the specific CHD diagnosis and fetal sex.
Further research is warranted to explore targeted progesterone interventions in specific subpopulations of fetuses with CHD.