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Progesterone Preeclampsia

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…

ClinicalTrials.gov IDNCT07448597
PhasePHASE4
Enrollment642
SponsorMedical University of South Carolina
Age18 Years
SexFEMALE
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Conditions studied

Preeclampsia, Hypertensive Disorder of Pregnancy

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.