NCT07448597

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
642

participants targeted

Target at P75+ for phase_4

Timeline
21mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

February 26, 2026

Last Update Submit

May 27, 2026

Conditions

PreeclampsiaHypertensive Disorder of Pregnancy

Keywords

Progesterone

Outcome Measures

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

    Antenatally and up to 6 weeks postpartum

Study Arms (2)

Control

NO INTERVENTION

Progesterone

EXPERIMENTAL
Drug: Progesterone supplementation

Interventions

Progesterone supplementationDRUG

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

Progesterone

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant individuals receiving prenatal care at participating clinics
  • \<12 weeks gestation with a viable intrauterine pregnancy
  • Age ≥18 years
  • English-speaking

You may not qualify if:

  • Unable or unwilling to self-administer vaginal progesterone
  • Inability or unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-EclampsiaToxemia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-Faculty

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05