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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
642
Patients in the progesterone arm will be randomized to receive progesterone supplementation while the control arm will not receive any additional intervention.
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 postpartum
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