Progesterone to Prevent Preeclampsia in Early Pregnancy
Official title: Progesterone Supplementation for the Prevention of Preeclampsia
Run by Medical University of South Carolina · NCT07448597 · Data updated 2026-11-12
This trial tests whether nightly vaginal progesterone started before 12 weeks can lower the chance of preeclampsia in low-risk pregnant people.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 642 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | August 1, 2028 |
| Study ends | August 1, 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07448597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals less than or equal to 12 weeks gestation with a viable intrauterine pregnancy, at least 18 years old, English-speaking, and able to self-administer vaginal progesterone.
✕Probably not a fit
Persons who cannot self-administer vaginal progesterone or who do not meet the eligibility criteria may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, controlled study compares nightly vaginal micronized progesterone (400 mg) given from before 12 weeks until 16 weeks of gestation with standard prenatal care. The primary goal is to see if early progesterone reduces the incidence of preeclampsia, with maternal and neonatal outcomes collected from medical records. Outcomes include preeclampsia development, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity. Participants are adult pregnant individuals receiving care at the study sites and must be English-speaking and able to self-administer the vaginal medication.
Why it matters
Potential benefit: If successful, early progesterone could reduce the risk of preeclampsia and improve maternal and newborn outcomes.
How similar studies have gone: Existing studies in related areas have shown mixed results; this trial tests an early-start approach in a low-risk population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.