Recruiting

Vaginal Progesterone

Sponsor:

Medical University of South Carolina

Code:

NCT07448597

Conditions

Preeclampsia

Hypertensive Disorder of Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Progesterone supplementation

Study Details

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.

Conditions

Preeclampsia

Hypertensive Disorder of Pregnancy

Study ID

NCT07448597

Start date

Aug 13, 2026

Status verified date

May, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

642 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: Progesterone

Interventions

Progesterone supplementation

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

Primary outcome measure

  • Development of preeclampsia [ Time Frame: Antenatally and up to 6 weeks postpartum ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Lauren Yacobucci, MD

7163415115yacobucc@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 17, 2026

Last verified

May, 2026

Keywords

  • Progesterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-17.