RecruitingPhase 4NCT07448597

Progesterone Preeclampsia

Progesterone Supplementation for the Prevention of Preeclampsia

Sponsor

Medical University of South Carolina

Enrollment

642 participants

Start Date

Aug 13, 2026

Study Type

INTERVENTIONAL

Conditions

Preeclampsia Hypertensive Disorder of Pregnancy

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Progesterone supplementation for people with hypertensive disorder of pregnancy and preeclampsia. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProgesterone supplementation

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