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NOT YET RECRUITING
NCT07448597
PHASE4

Progesterone Preeclampsia

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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.

Official title: Progesterone Supplementation for the Prevention of Preeclampsia

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

642

Start Date

2026-05-01

Completion Date

2028-05-01

Last Updated

2026-03-04

Healthy Volunteers

Yes

Interventions

DRUG

Progesterone supplementation

Patients in the progesterone arm will be randomized to receive progesterone supplementation while the control arm will not receive any additional intervention.