NCT02690129Unknown不适用
Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
Omar Mamdouh Shaaban1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Miscarriage rate up to 28 weeks of gestation
研究概览
简要总结
The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant with gestational age less than 24 weeks
- •Presented by bleeding with or without pain
- •Single viable fetus (confirmed by Ultrasound examination)
- •Accepting to have vaginal medication
排除标准
- •Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
- •Hypersensitivity to progesterone
- •Any documented congenital fetal anomaly in the current pregnancy
- •Women received hormonal treatment in the current pregnancy
- •Patients conceived via ART
研究组 & 干预措施
Group I (Progesterone Group)
Active Comparator
Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours.
- Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days.
- If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic .
- Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation.
干预措施: Vaginal Progesteron (Drug)
Group II ( Control group)
Placebo Comparator
Will follow the same plan of management without progesterone support.
干预措施: Vaginal Progesteron (Drug)
结局指标
主要结局
Miscarriage rate up to 28 weeks of gestation
时间窗: Completed 28th week
次要结局
- Gestational age at delivery or termination of pregnancy(Number of completed weeks at the time of delivery)
研究者
Omar Mamdouh Shaaban
Clinical Professor
Assiut University
研究点 (1)
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