RecruitingPhase 4

Progesterone Preeclampsia

Progesterone Supplementation for the Prevention of Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether progesterone, a hormone placed in the vagina each night, lowers the risk of preeclampsia, a pregnancy problem involving high blood pressure. It is for people with low-risk pregnancies who are less than 12 weeks pregnant. Participants are assigned by chance to use 400 mg of progesterone nightly through week 16 or get usual pregnancy care without progesterone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Get pregnancy care at a clinic taking part in the study.
  • Be less than 12 weeks pregnant, with a pregnancy growing inside the womb that is able to continue developing.
  • Be age 18 or older.
  • Speak English.

Who can't join

  • Cannot or do not want to place progesterone in the vagina yourself.
  • Cannot or do not want to give informed consent, which means agreeing after learning about the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

SC