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NCT07448597PHASE4RecruitingAccepts Healthy Volunteers

Progesterone Preeclampsia

Medical University of South Carolina

Start Date

8/13/2026

Completion Date

8/1/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Pregnant individuals receiving prenatal care at participating clinics * \<12 weeks gestation with a viable intrauterine pregnancy * Age ≥18 years * English-speaking Exclusion Criteria: * Unable or unwilling to self-administer vaginal progesterone * Inability or unwillingness to provide informed consent

Interventions

DRUG

Progesterone supplementation

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Conditions

PreeclampsiaHypertensive Disorder of Pregnancy

Locations

Medical University of South Carolina

Charleston, South Carolina 29401

United States