NCT04788108已完成4 期
Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- continue pregnancy more than 20 weeks gestation
研究概览
简要总结
This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy with gestational age 6 - 20 weeks
- •threatened abortion
- •confirmed intrauterine pregnancy with a viable fetus by ultrasound
排除标准
- •history of recurrent miscarriage
- •having endocervical polyp
- •having infection such as pneumonia, pyelonephritis, septicemia
- •having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
- •having cancer
- •having coagulation defect
- •allergy to dydrogesterone
研究组 & 干预措施
Dydrogesterone
Active Comparator
dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.
干预措施: Dydrogesterone (Drug)
Placebo
Placebo Comparator
placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
continue pregnancy more than 20 weeks gestation
时间窗: at 20 weeks gestation
percentage of cases with continue pregnancy more than 20 weeks gestation
次要结局
- preterm delivery less than 34 weeks(at 34 weeks gestation)
- preterm delivery less than 37 weeks(at 37 weeks gestation)
- placenta previa(31 weeks)
- abruptio placenta(31 weeks)
- Intrauterine growth restriction(31 weeks)
- neonatal complications(31 weeks)
- side effects(6 weeks)
- compliance(6 weeks)
- maternal satisfaction(6 weeks)
- time until bleeding stops(6 weeks)
研究者
Vorapong Phupong
Head of Placental Related Diseases Research Unit, Principal Investigator, Professor
Chulalongkorn University
研究点 (1)
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