The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurence of cesarean section
研究概览
简要总结
The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single, live fetus
- •Cephalic (head-first) presentation
- •Reassuring fetal health assessment
- •Gestational age between 23 and 42 weeks
- •Maternal age 18 and above
- •Bishop score less than 8 in primigravidae
- •Bishop score less than 6 in multigravidae
排除标准
- •Fetal demise
- •Fetal malpresentation
- •Estimated fetal weight less than 500 grams or more than 4000 grams
- •Placenta previa
- •Non-reassuring fetal health assessment
- •Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.
- •History of cesarean section
- •Rupture of amniotic membrane
- •Latex allergy
- •Spontaneous labor
- •Other contraindication to vaginal delivery
- •Allergy to misoprostol of cook catheter
研究组 & 干预措施
Cook Catheter, Oral Misoprostol
Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours.
干预措施: Misoprostol (Drug)
Cook Catheter, Oral Placebo
Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours.
干预措施: Placebo (Other)
结局指标
主要结局
Occurence of cesarean section
时间窗: Within 96 hours from the commencement of the Induction of Labor
次要结局
- Time from start of induction of labor to vaginal delivery(24, 48 and 72 hours)
研究者
Meg Hill
Fellow, Maternal Fetal Medicine
University of Arizona