Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Priming to delivery interval
研究概览
简要总结
The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.
详细描述
Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term 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
- None
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
- •Viable singleton pregnancy
- •Cephalic presentation
- •Bishop score <7
- •At term (>=37+0 weeks of gestation)
- •Nulliparous women
排除标准
- •Gestation <37weeks
- •Multiple pregnancy
- •Bishop score <7
- •Malpresentation
- •Contraindication to vaginal delivery
- •Previous Caesarean section
- •History of myomectomy
- •Maternal fever
- •Suspected infection
- •Abnormal fetal heart-rate patterns
- •Rupture of membranes
- •Intrauterine growth restriction
- •Not fit for giving consent
- •Allergic to Propess or PGE2
结局指标
主要结局
Priming to delivery interval
时间窗: 1 year
Time for priming (device placement) to delivery interval
次要结局
- Suspected intrauterine infection rate(1 year)
- Caesarean section rate(1 year)
- Need of induction with oxytocin(1 year)
- Vaginal delivery within 24 hours after priming(1 year)
- Priming to induction interval(1 year)
- Failed induction rate(1 year)
- Length of hospital stay(1 year)
- Vaginal delivery rate(1 year)
- Uterine hyperstimulation(1 year)
- Amount of oxytocin use(1 year)
- Malpresentation after priming(1 year)
- Primary postpartum haemorrhage(1 year)
- Maternal satisfaction with the procedure(1 year)