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Progesterone Preeclampsia

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later May 1, 2028 → Aug 1, 2028
See other at-risk trials from Medical University of South Carolina

Record History

  1. Recruitment opened Primary and study completion pushed from May 1, 2028 to Aug 1, 2028 · Start date changed from estimate of Aug 1, 2026 to Aug 13, 2026v3 Show 2 more changesShow less
    • Primary and study completion pushed from May 1, 2028 to Aug 1, 2028
    • Start date changed from estimate of Aug 1, 2026 to Aug 13, 2026
  2. Start date: May 1, 2026 to Aug 1, 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07448597
Lead Sponsor Medical University of South Carolina
Conditions Preeclampsia, Hypertensive Disorder of Pregnancy
Enrollment 642 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov