drugset / Trial / NCT07448597

Progesterone Preeclampsia

NCT07448597

Phase 4 Not yet recruiting 642 enrolled Medical University of South Carolina
RandomizedParallel-groupOpen-labelPrevention

Summary

This randomized controlled trial evaluates whether nightly vaginal micronized progesterone (400 mg) initiated before 12 weeks' gestation reduces the incidence of preeclampsia in low-risk pregnant individuals. Participants will be randomly assigned (1:1) to receive either vaginal progesterone through 16 weeks' gestation or routine prenatal care without progesterone. Maternal and neonatal outcomes-including development of preeclampsia, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.

Timeline

Start
2026-08-01
Primary completion
2028-05-01
Completion
2028-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 400 mg Other

Indications