NCT07448597

Progesterone Preeclampsia

Progesterone Supplementation for the Prevention of Preeclampsia

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 642 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preeclampsia
• Hypertensive Disorder of Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2026-03-04
• Last updated: 2026-03-04