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PREMISENCT07796737

Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss

StatusNot Yet Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 79 words Show 6 more changesShow less
    • Interventions modified
    • Enrollment target: 264 to 268
    • Secondary endpoints: 5 to 7
    • Study description expanded, about 200 words
    • Site contact updated
    • Study title expanded, about 1 word
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Live Birth Rate
Timeframe: At delivery (≥24+0 weeks of gestation)

Secondary (7)

Ongoing Pregnancy Rate at 22 Weeks
Maternal Complications
Neonatal Outcomes:
Safety of the trial medication
Adherence and Tolerability:
Show 2 moreShow less
Incidence of Fetal Growth Restriction
Gestational Age at Delivery

Arms and interventions

ARM ANo intervention

Participants receive routine antenatal care according to local Czech clinical practice. No investigational medicinal product or active pharmacological treatment for recurrent pregnancy loss is administered in this arm. Folic acid or standard prenatal vitamins are recommended. Concomitant medication is recorded.

ARM BExperimental

Participants receive vaginal micronized progesterone and daily subcutaneous enoxaparin from 5-7 weeks of gestation following confirmation of intrauterine pregnancy, with treatment continued as specified below through 36+0 weeks unless earlier discontinuation is clinically indicated or delivery occurs.

Drugs: Vaginal Micronized Progesterone (Progesterone Besins), Enoxaparin (Clexane)

Sites

1 site in 1 country

  • General University Hospital in PraguePrague, Czechia