Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Miscarriages

Randomized Open-Label Controlled Trial Evaluating the Efficacy of the Combination of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss

The objective of the trial is to assess whether the combination of enoxaparine (LMWH) with progesterone increases the live birth rate compared to standard of care (no active treatment) in women with unexplained recurrent pregnancy loss.

Inclusion Criteria:

• History of ≥2 consecutive unexplained miscarriages before 20 weeks of gestation.
• Confirmed intrauterine pregnancy by ultrasound and/or serum β-hCG (≥5 weeks).
• Willingness to follow study procedures (progesterone use, possible daily - injections) and provide written informed consent.
• No medical contraindication to progesterone or LMWH.

Exclusion Criteria:

• Documented antiphospholipid syndrome or any current anticoagulant requirement.
• Anatomical abnormalities (e.g., significant uterine malformations, large fibroids) conclusively linked to RPL.
• Known hypersensitivity to enoxaparine or heparins, or prior heparin-induced thrombocytopenia (HIT).
• Use of systemic steroids (beyond standard pregnancy doses) for other immunological or inflammatory conditions.
• Severe renal insufficiency (eGFR <30 mL/min), advanced liver disease, or other clinically significant systemic autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) that may affect pregnancy or study compliance.
• Inability or unwillingness to comply with study requirements (language barriers, severe psychiatric conditions, etc.).
• Abnormal karyotype