EUCTR2009-011208-42-NL进行中（未招募）1 期
First trimester progesterone therapy to reduce miscarriages in women with a history of unexplained recurrent miscarriages: A randomised, double blind, placebo-controlled, multi-centre trial [The PROMISE (PROgesterone in recurretn MIScarriagE) Trial] Funded by NIHR-HTA(UK) 08/38/01 for £1.2 million - Progesterone in recurrent miscarriage (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 RM (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 RM (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)
- •9. previous enrolment in the Promise trial
研究者
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