Clinical Trial

Progesterone Preeclampsia

Not Yet Recruiting Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-26.
Trial Details
NCT Number NCT07448597
Lead Sponsor Medical University of South Carolina
Conditions Preeclampsia, Hypertensive Disorder of Pregnancy
Enrollment 642 participants
Start Date 2026-08-01
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-29