Progesterone Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Hypertensive Disorder of Pregnancy Infections Pre-Eclampsia Pregnancy Complications Toxemia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location status: Recruiting

Location contact

Lauren Yacobucci, MD

CONTACT

[email protected]

7163415115

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone supplementation

Drug

Patients in the progesterone arm will be randomized to receive progesterone supplementation while the control arm will not receive any additional intervention.

Primary outcomes

Development of preeclampsia

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Progesterone Supplementation for the Prevention of Preeclampsia

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 4, 2026
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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