Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up Women only

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.

More Preeclampsia trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment642 (estimated)
SponsorMedical University of South Carolina
Academic / other
Locations1 site (Charleston, South Carolina)
StatusRecruiting
StartedAugust 13, 2026
Main results expectedAugust 1, 2028
Study endsAugust 1, 2028
Registry record updatedAugust 17, 2026
Trial IDNCT07448597 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

  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.