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Progesterone supplementation / Hypertensive Disorder of Pregnancy / Preeclampsia · Phase 4 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 4 randomized trial designed to test whether vaginal micronized progesterone (400 mg nightly) initiated before 12 weeks' gestation reduces preeclampsia incidence in low-risk pregnant individuals. The trial is currently recruiting and no efficacy results have been reported; the design supports a future evidence assessment but no clinical evidence is available at this time.
Phase 4, Interventional, Randomized, Parallel, Open label, Prevention purpose. Preeclampsia, Hypertensive Disorder of Pregnancy; Female; age from 18 Years; accepts healthy volunteers. Intervention: Progesterone. Compared with: Control — No Intervention. n = 642. 1 site: United States.
This is a registered Phase 4 randomized trial designed to test whether vaginal micronized progesterone (400 mg nightly) initiated before 12 weeks' gestation reduces preeclampsia incidence in low-risk pregnant individuals. The trial is currently recruiting and no efficacy results have been reported; the design supports a future evidence assessment but no clinical evidence is available at this time.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a registered, actively recruiting Phase 4 RCT with no published results; the study design is sound but no efficacy data are yet available to assess.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07448597). This is a study registration, not published results. Lead sponsor: Medical University of South Carolina. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 642 participants (ESTIMATED). Conditions: Preeclampsia, Hypertensive Disorder of Pregnancy. Interventions: DRUG: Progesterone supplementation. Primary outcome measures: Development of preeclampsia , Antenatally and up to 6 weeks postpartum. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.