Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 4
- 主要终点
- Rate of Vaginal Delivery
研究概览
简要总结
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
详细描述
Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.
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
- Single (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
- 否
入选标准
- •Pregnant woman scheduled for induction of labor.
- •Age between 18 and 45 years.
- •Understanding and capable to sign informed consent.
- •Singleton pregnancy.
- •Gestational age ≥ 37 0/7 weeks.
- •Live fetus in cephalic presentation.
- •Intact membranes.
- •Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.
排除标准
- •Iodine allergy.
- •Active labor or oxytocin has been administered.
- •Chorioamnionitis.
- •Prior uterine or cervical surgery.
- •Non reassuring fetal status requiring immediate delivery.
- •Non-cephalic fetal presentation.
- •Active vaginal bleeding from cervical os.
- •Placenta previa.
- •EFW > 5000 gm(non diabetic) or > 4500gm (diabetic).
- •Other contraindication to vaginal delivery.
结局指标
主要结局
Rate of Vaginal Delivery
时间窗: Through study completion, an average of 1-2 years
Proportion of patients that delivered vaginal. (%)
次要结局
- Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation(1-2 days)
- Change in Bishop Scores(12-24 hrs)
- Operative Deliveries(1-4 days)
- Cesarean Deliveries(1-4 days)
- Time of Vaginal Delivery(2-4 days)