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

NCT07796737 · tracked via the Priya Life Science Czechia tracker

Sponsor

General University Hospital, Prague

Phase

Phase 3

Started

2026-12-01

Last updated

2026-10-28

Condition(s) studied

Pregnancy LossPregnancy Loss, Early

Investigational drug(s) / intervention(s)

Vaginal Micronized Progesterone (Progesterone Besins) →Enoxaparin (Clexane) →

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

40 Years

Healthy volunteers

Inclusion Criteria 1. Women aged 18-40 years. 2. History of at least two consecutive unexplained miscarriages. 3. Confirmed pregnancy at 5-7 weeks of gestation, with a singleton intrauterine pregnancy confirmed by ultrasound before randomization. 4. Willingness to comply with study procedures and, if assigned to the intervention arm, to use vaginal progesterone and administer daily subcutaneous enoxaparin injections; ability to provide written informed consent. 5. No medical contraindication to progesterone or low-molecular-weight heparin. Exclusion Criteria 1. Documented antiphospholipid syndrome or any current anticoagulant requirement. 2. Clinically significant thyroid disease requiring treatment adjustment. 3. Anatomical abnormalities (such as significant uterine malformations or large fibroids) conclusively linked to recurrent pregnancy loss. 4. Known hypersensitivity to enoxaparin or heparins, or prior heparin-induced thrombocytopenia. 5. Use of systemic steroids beyond standard pregnancy doses for other immunological or inflammatory conditions. 6. Severe renal insufficiency (estimated glomerular filtration rate below 30 mL/min), advanced liver disease, or other clinically significant systemic autoimmune disease (such as systemic lupus erythematosus or rheumatoid arthritis) that may affect pregnancy or study compliance. 7. Inability or unwillingness to comply with study requirements (for example, language barriers or severe psychiatric conditions). 8. Known parental chromosomal abnormalities. 9. Multiple pregnancy. 10. Current use of progesterone or other progestogen therapy for luteal support at screening or randomization, including luteal support after assisted reproductive technology, such as in vitro fertilization or frozen embryo transfer.

Primary outcome measure(s)

Live Birth Rate — At delivery (≥24+0 weeks of gestation)
Proportion of randomized participants who deliver at least one live-born infant at 24+0 weeks of gestation or later. Live birth status and gestational age at delivery will be ascertained using the structured participant-completed postpartum questionnaire.

Trial sites (1)

Facility	City	Region	Status
General University Hospital in Prague	Prague	Czechia

More General University Hospital, Prague trials in Czechia

Molecular Markes of Fibrosis of Endometriosis and Their Use in Predicting Disease Severity Recruiting

Regression of Cervical Precancerous Lesions and Associated Risk Factors Recruiting

Effect of Visual Feedback From the SpiroGym Mobile Application Recruiting

Bone Marrow Adipose Tissue in Relation to Bone and Energy Metabolism in Obesity and Type 2 Diabetes Mellitus Recruiting

PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled Tiotropium Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07796737 on ClinicalTrials.gov ↗ ← All trials in Czechia