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Not yet recruiting NCT07448597

Progesterone Preeclampsia

Phase IV Interventional Preeclampsia Hypertensive Disorder of Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progesterone supplementation.
Who it may be relevant to
Registry conditions: Preeclampsia, Hypertensive Disorder of Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Progesterone Supplementation for the Prevention of Preeclampsia

Overview

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

  • Drug 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 measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07448597 · Pro00145923

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗