EUCTR2009-011208-42-GB进行中（未招募）1 期
First trimester progesterone therapy in women with a history of unexplained recurrent miscarriages: A randomised, double-blind, placebo-controlled, multi-centre trial [The PROMISE (PROgesterone in recurrent MIScarriagE) Trial] Funded by NIHR-HTA(UK) 08/38/01 for £1.2million - Progesterone in Recurrent Miscarriages (PROMISE) Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 836
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women with unexplained recurrent miscarriages (3 or more first trimester miscarriages). 2. Age 18 - 39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy). 3. Spontaneous conception (as confirmed by urinary pregnancy tests). 4. Willing and able to give informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Inability to conceive spontaneously within 1 year of recruitment. 2. Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice). 3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy). 4. Fibroids distorting the uterine cavity. 5. Abnormal parental karyotype. 6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated): e.g. diabetes, thyroid disease and SLE. 7. Current heparin therapy. 8. Contraindications to progesterone use (e.g. allergy to progesterone).
研究者
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