Progesterone for Neurodevelopment in Fetuses With Congenital Heart Defects: A Randomized Clinical Trial
ABSTRACT
Importance: Children with congenital heart defects (CHD) have seen minimal improvement in neurodevelopmental outcomes over the past 20 years.
Objectives: Evaluate the feasibility and tolerability of maternal progesterone therapy and its impact on neurodevelopment in fetuses with CHD.
Design, Setting, and Participants: A double-blinded clinical trial was conducted at a children’s hospital from July 2014 to November 2021, involving maternal-fetal dyads carrying fetuses with CHD identified before 28 weeks’ gestational age. Exclusion criteria included major genetic anomalies and known contraindications to progesterone.
Intervention: Participants were randomized to receive vaginal progesterone or placebo, 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 subgroups included cardiac diagnosis, fetal sex, genetic profile, and maternal-fetal environment.
Results: The study enrolled 102 fetuses, primarily with hypoplastic left heart syndrome (HLHS) and transposition of the great arteries (TGA). The mean motor score did not significantly differ for progesterone compared with placebo. Subgroup analyses suggested varying responses to progesterone based on cardiac diagnosis and fetal sex.
Conclusions and Relevance: The overall effect of maternal progesterone therapy was not statistically different from 0. Subgroup analyses indicated potential variability in response to progesterone among different CHD diagnoses and fetal sexes.
Trial Registration: ClinicalTrials.gov Identifier: NCT02133573.
Value of Clinical Trials and AI in Healthcare
Clinical trials are essential for developing safe and effective treatments, and it’s crucial to integrate their benefits into everyday medical practice. DocSym, an AI-driven platform, consolidates ICD-11 standards, clinical protocols, and research into an easily accessible knowledge base for clinicians.
In today’s healthcare environment, streamlining operations is vital. Mobile apps can support scheduling, monitoring treatments, and telemedicine, making it easier to manage patient care and expand services digitally.
By leveraging AI, clinics can improve workflows, enhance patient outcomes, and reduce paper-based routines. Learn more about how we can help at aidevmd.com.
