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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Sponsor: General University Hospital, Prague
Summary
This prospective, single-centre, open-label, randomized Phase III superiority trial will enroll approximately 268 women aged 18-40 years with at least two consecutive unexplained miscarriages and a singleton intrauterine pregnancy confirmed by ultrasound at 5-7 weeks of gestation. Participants will be randomly assigned in a 1:1 ratio to standard antenatal care without active pharmacological treatment for recurrent pregnancy loss or to vaginal micronized progesterone plus subcutaneous enoxaparin. The primary outcome is live birth at or beyond 24+0 weeks of gestation. Study follow-up continues through six weeks postpartum. Delivery and postpartum outcomes will be obtained remotely using a structured participant-completed questionnaire. An optional exploratory translational sub-study involving one maternal blood sample at 10-12 weeks requires separate informed consent.
Official title: Randomized Open-Label Controlled Trial Evaluating the Efficacy of the Combination of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2026-12-01
Completion Date
2030-12-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Vaginal Micronized Progesterone (Progesterone Besins)
Vaginal micronized progesterone 400 mg twice daily (total 800 mg/day) from treatment initiation at 5-7 weeks through 16+0 weeks of gestation, followed by 200 mg vaginally once daily at night from 16+1 through 36+0 weeks of gestation. Treatment may be interrupted or discontinued for protocol-specified safety reasons
Enoxaparin (Clexane)
Subcutaneous enoxaparin once daily, at a prophylactic dose based on maternal body weight at randomization: 4,000 anti-Xa IU (40 mg) for participants weighing less than 100 kg, or 6,000 anti-Xa IU (60 mg) for participants weighing 100 kg or more. Treatment starts at 5-7 weeks following pregnancy confirmation and continues through 36+0 weeks of gestation unless medically discontinued earlier. If delivery occurs before 36+0 weeks, treatment stops at the onset of labour.
Locations (1)
General University Hospital in Prague
Prague, Czechia