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NCT07448597
Progesterone Preeclampsia
Conditions: Preeclampsia, Hypertensive Disorder of Pregnancy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 642
Sponsor: Medical University of South Carolina
Location: Medical University of South Carolina Charleston South Carolina
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
Inclusion Criteria:
* Pregnant individuals receiving prenatal care at participating clinics
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Source: ClinicalTrials.gov (NCT07448597). StuddyBuddy aggregates publicly available trial information.
