Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Number of patients continued the pregnancy beyond 20 weeks gestation.
研究概览
简要总结
In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).
详细描述
Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life.
. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.
Explore differential or subgroup effects of progesterone in prognostic subgroups.
. Perform an economic evaluation for cost-effectiveness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
- •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).
- •Spontaneous conception (as confirmed by urinary pregnancy tests).
- •Willing and able to give informed consent.
排除标准
- •Age less than twenty or above forty years old.
- •Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice)
- •Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- •Fibroids distorting uterine cavity.
- •Abnormal parental karyotype.
- •Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
研究组 & 干预措施
Progesterone group
progesterone (400 mg pessary, once daily)
干预措施: Progesterone (Drug)
Placebo group
Placebo (pessary, once daily)
干预措施: Placebo (Other)
结局指标
主要结局
Number of patients continued the pregnancy beyond 20 weeks gestation.
时间窗: 2 years
次要结局
- Number of miscarriages(2 years)
研究者
alaa eldeen mahmoud ismail
M D
Woman's Health University Hospital, Egypt