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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Miscarriages (PREMISE)

2026年9月3日 更新者：Zdenek Lastuvka、General University Hospital, Prague

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

264

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 捷克语
      • Prague、捷克语、12800
        • General University Hospital in Prague
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：ARM A
standard care with no active treatment
实验性的：ARM B
Intervention Arm (Progesterone + Enoxaparine)
药品：Vaginal micronized progesterone
Vaginal micronized progesterone 800 mg daily administered in two divided doses .
药品：Enoxaparin (LMWH)
Administered subcutaneously once daily at a weight-adjusted prophylactic dose according to body weight or applicable local guidelines.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Live Birth Rate
大体时间：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.
At delivery (≥24+0 weeks of gestation)

次要结果测量

结果测量
措施说明
大体时间
Ongoing Pregnancy Rate at 22 Weeks
大体时间：From enrollment to the end of 22 weeks of the index pregnancy.
Proportion of randomized participants with an ongoing intrauterine pregnancy at 22+0 weeks of gestation, confirmed by ultrasound demonstrating fetal cardiac activity.
From enrollment to the end of 22 weeks of the index pregnancy.
Maternal Complications
大体时间：From enrollment to the end of treatment at 6 weeks post-labor.
Incidence of pregnancy-related complications, including preeclampsia (defined by ISSHP), gestational hypertension, gestational diabetes, placental abruption, postpartum hemorrhage (defined as estimated blood loss >500 mL following vaginal delivery or >1000 mL following cesarean section).
From enrollment to the end of treatment at 6 weeks post-labor.
Neonatal Outcomes:
大体时间：From enrollment to the end of treatment at 6 weeks post-labor.
Birth weight (grams), APGAR scores at 1 and 5 minutes post-delivery (APGAR at 10 minutes may be recorded if available), admission to neonatal care unit (NICU), and presence of congenital anomalies confirmed postnatally.
From enrollment to the end of treatment at 6 weeks post-labor.
Safety of the trial medication
大体时间：From enrollment to the end of treatment at 6 weeks post-labor.
Incidence of major bleeding events (overt bleeding requiring transfusion, surgical intervention, or hemodynamic intervention) and minor bleeding events (mucosal or injection-site bleeding), thrombocytopenia (defined as platelet count <100,000/μL), hypersensivity, and injection-site reactions.
From enrollment to the end of treatment at 6 weeks post-labor.
Adherence and Tolerability:
大体时间：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.
Treatment discontinuation rate and reasons for discontinuation (including adverse events); participant-reported injection-site pain associated with LMWH treatment, assessed using a numerical rating scale from 0 (no pain) to 10 (worst imaginable pain); participant-reported missed doses of study treatment and reasons for missed doses; and completeness of medication diaries.
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

General University Hospital, Prague

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年9月1日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PREMISE LMWH-RPL_Protocol_V1.0

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

GDPR requirements

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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