Mechanical Induction of Labor in Women With Previous Cesarean Section and Premature Rupture of Membranes Who Desire TOLAC: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Vaginal birth after cesarean (VBAC) rates
研究概览
简要总结
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Only patients who meet the following criteria will be approached.
- •Singleton Pregnancy
- •Previous single cesarean section
- •At least 12 months have elapsed since the previous caesarean delivery
- •Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
- •Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
- •Vertex presentation well applied to the cervix
- •Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
- •Absence of significant and regular uterine contraction (<3/10Min).
- •Willingness to comply with the protocol for the duration of the study.
- •Have signed an informed consent (including a TOLAC consent form).
排除标准
- •Patients having any of the following conditions will be excluded from the study:
- •Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery < 12 months).
- •Regular uterine contractions (>3/10Min).
- •Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
- •Meconium stained amniotic fluid.
- •Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
- •Suspected placental abruption or a significant hemorrhage.
- •Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
研究组 & 干预措施
Double balloon catheter for induction of labor
in this group a trans-cervical double balloon catheter will be inserted. Following device insertion, 20 minutes of external monitoring is performed. The patient will be transferred to the Ob/Gyn ward for hospitalization. 12 hours after insertion of the device the balloons are deflated and the device removed. At this stage the patient is assessed for a second Bishop score and expectant management is resuming.
干预措施: Double Balloon catheter for induction of labor (Device)
Expectant management
Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues.
结局指标
主要结局
Vaginal birth after cesarean (VBAC) rates
时间窗: 5 days
次要结局
- PROM to delivery interval (time)(5 days)
- intrapartum and post-partum infection rates(5 days)
- Cesarean section rates(5 days)
研究者
Gil Gutvirtz MD
Ob/Gyn Resident
Soroka University Medical Center