NCT05997563招募中4 期
Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- latency period
研究概览
简要总结
This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.
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
- None
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 24-33 weeks 6 days
- •preterm labor
- •received treatment with tocolysis and corticosteroids
排除标准
- •conditions that need immediate delivery such as fetal distress, chorioamnionitis
- •have medical complications such as heart disease, seizure
- •fetal anomalies
- •cervical dilatation more than 5 cm
- •allergy to progesterone
- •contraindication to progesterone
- •contraindication to tocolytic use
研究组 & 干预措施
Micronized progesterone
Active Comparator
干预措施: Micronized progesterone (Drug)
结局指标
主要结局
latency period
时间窗: 13 weeks
time from preterm labor to delivery
次要结局
- gestational age at delivery(13 weeks)
- good quality of life(13 weeks)
- Time to the recurrence of uterine contractions(13 weeks)
- preterm delivery less than 37 weeks(13 weeks)
- neonatal complications(13 weeks)
- preterm delivery less than 34 weeks(10 weeks)
- side effects(13 weeks)
- compliance(13 weeks)
- good satisfaction(13 weeks)
研究者
Vorapong Phupong
Professor Vorapong Phupong
Chulalongkorn University
研究点 (1)
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