Progesterone Preeclampsia
Recruiting · NCT07448597 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Medical University of South Carolina - Charleston, South Carolina, United States