Hypertensive Disorder of Pregnancy, Preeclampsia
Conditions
Keywords
Progesterone
Brief summary
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.
Interventions
Patients in the progesterone arm will be randomized to receive progesterone supplementation while the control arm will not receive any additional intervention.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of preeclampsia | Antenatally and up to 6 weeks postpartum | 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 |
Countries
United States
Outcome results
None listed