Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time from preterm labor pain to delivery
研究概览
简要总结
This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.
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
- 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 pregnant women with preterm labor, gestational age 24-34 weeks
排除标准
- •have indicated preterm birth
- •allergy to progesterone
- •fetal anomalies
- •cervical dilate > 5 cm.
- •have medical disease
- •have obstetric complication
研究组 & 干预措施
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
干预措施: progesterone (Drug)
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
干预措施: Tocolytics (Drug)
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
干预措施: Steroids (Drug)
no medication
only tocolysis plus corticosteroid for 48 hours
干预措施: Tocolytics (Drug)
no medication
only tocolysis plus corticosteroid for 48 hours
干预措施: Steroids (Drug)
结局指标
主要结局
Time from preterm labor pain to delivery
时间窗: 9 weeks
time since preterm labor to delivery
次要结局
- number of pregnant women deliver before 34 weeks(6 weeks)
- Number of newborn with respiratory distress syndrome(9 weeks)
- Number of newborn with necrotizing enterocolitis(9 weeks)
- gestational age at delivery(9 weeks)
- number of pregnant women deliver before 37 weeks(9 weeks)
- Number of newborn with intraventricular hemorrhage(9 weeks)
- Number of newborn with sepsis(9 weeks)
研究者
Vorapong Phupong
Head of Placental Related Diseases Research Unit
Chulalongkorn University