Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Time from start of cervical ripening to delivery
研究概览
简要总结
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
详细描述
Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.
We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).
排除标准
- •Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
- •Simplified Bishop score must be <6 and cervical dilation <2 cm.
- •Women must be able to give informed consent.
- •Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
- •Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.
研究组 & 干预措施
Trans-cervical cervical balloon
17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.
干预措施: Trans-cervical cervical balloon (Device)
Hygroscopic cervical dilators
Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.
干预措施: Hygroscopic cervical dilator (Device)
结局指标
主要结局
Time from start of cervical ripening to delivery
时间窗: 720-2160 minutes
Time in minutes from placement of cervical ripening agent to delivery
次要结局
- Pain of insertion(First hour)
- Pain over duration of cervical ripening(12-14 hours)
- Patient satisfaction with cervical ripening agent(24-36 hours)