Progesterone Preeclampsia

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant individuals receiving prenatal care at participating clinics

<12 weeks gestation with a viable intrauterine pregnancy

Age ≥18 years

English-speaking

Disqualifiers

Unable or unwilling to self-administer vaginal progesterone

Inability or unwillingness to provide informed consent

Trial design

Treatments tested in this trial

  • Progesterone supplementation

Treatment groups

642 Participants
are divided into 2 treatment groups

Locations

This trial has no locations