NCT07796737尚未招募3 期
Randomized Open-Label Controlled Trial Evaluating the Efficacy of the Combination of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
General University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2026年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Live Birth Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
ARM A
No Intervention
standard care with no active treatment
ARM B
Experimental
Intervention Arm (Progesterone + Enoxaparine)
干预措施: Vaginal micronized progesterone (Drug)
ARM B
Experimental
Intervention Arm (Progesterone + Enoxaparine)
干预措施: Enoxaparin (LMWH) (Drug)
结局指标
主要结局
Live Birth Rate
时间窗: 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.
次要结局
- Ongoing Pregnancy Rate at 22 Weeks(From enrollment to the end of 22 weeks of the index pregnancy.)
- Maternal Complications(From enrollment to the end of treatment at 6 weeks post-labor.)
- Neonatal Outcomes:(From enrollment to the end of treatment at 6 weeks post-labor.)
- Safety of the trial medication(From enrollment to the end of treatment at 6 weeks post-labor.)
- Adherence and Tolerability:(Treatment discontinuation: from initiation at 5-7 weeks' gestation to 36+0 weeks or delivery. Pain and missed-dose outcomes: assessed at 20 and 34 weeks' gestation and 6 weeks postpartum.)
研究者
Zdenek Lastuvka
Principal investigator
General University Hospital, Prague
研究点 (1)
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