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Taking people in United StatesPhase 4

Tests progesterone to see whether it prevents preeclampsia in pregnancy

Tests vaginal progesterone in low-risk pregnant adults to study preeclampsia.

Plain-language title generated from the registry record
Registry title: Progesterone Preeclampsia

Key facts

Where
Charleston, United StatesSee the site
Phase
Phase 4

Where in United States

  • Medical University of South CarolinaCharleston, United StatesTaking people

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Trial details

Who runs it
Medical University of South Carolina
Trial code
NCT07448597
Record updated
17 August 2026
Original description
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.Read full original descriptionShow less

Progesterone Supplementation for the Prevention of 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 morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.

Inclusion: Pregnant individuals receiving prenatal care at participating clinics; <12 weeks gestation with a viable intrauterine pregnancy; Age ≥18 years; English-speaking.

Exclusion: Unable or unwilling to self-administer vaginal progesterone; Inability or unwillingness to provide informed consent.

ClinicalTrials.gov NCT07448597