Progesterone Preeclampsia
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Progesterone supplementation
DrugPatients in the progesterone arm will be randomized to receive progesterone supplementation while the control arm will not receive any additional intervention.
Treatment groups
642 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: ProgesteroneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Development of preeclampsia
Defined as new onset systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 on two occasions at least 4 hours apart, after 20 weeks gestation, with proteinuria or evidence of maternal acute kidney impairment, liver dysfunction, neurologic features, hemolysis, or thrombocytopenia
Time frame
Antenatally and up to 6 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov