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NCT07448597RecruitingPhase 4

Progesterone Preeclampsia

Progesterone Supplementation for the Prevention of Preeclampsia

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
642 (estimated)
First submitted
26 Feb 2026
Start date
13 Aug 2026
Primary completion date
1 Aug 2028
Lead sponsor
Medical University of South Carolina
NCT number
NCT07448597

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 642
  • From 13 Aug 2026 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Unable or unwilling to self-administer vaginal progesterone
  • Inability or unwillingness to provide informed consent

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.