Prospective Collection of Data About the Use of the Dilapan-S Osmotic Dilator in Pre-induction of Labor in Women With/Without Caesarean Section in Their History
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Cervix (Bishop) score
研究概览
简要总结
Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.
详细描述
Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single pregnancy
- •Pregnancy more than 36 weeks
- •Vertex presentation of the fetus
- •Cervix Score less than 4 points
排除标准
- •Contraindication to vaginal delivery
- •Pathological fetal station
- •States after uterine body surgery - except for Caesarean section
- •Clinical signs of uterine, vaginal or vulvar infection
- •Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)
结局指标
主要结局
Cervix (Bishop) score
时间窗: Before pre-induction of labor performance and up to 24 h after pre-induction of labor
To evaluate, based on the value obtained in the Cervix Score, the efficacy of use of the Dilapan-S device in the indication labor pre-induction, and to compare outcomes in patients with/without a history of Caesarean section.
次要结局
- Total duration of pre-induction(From Dilapan-S rods insertion up to 24 hours)
- Number of dilators inserted(At the moment of Dilapan-S insertion up to 24 hours until their removal)
- Apgar score(At 1st, 5th and 10th minute after delivery)
- The course of delivery (vaginally or Caesarean section)(From active phase of labor up to 1 day after delivery)
- Uterine contractions(From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase)
- pH of the fetus(Up to 10 minutes after delivery)
- Infection complications of mother / fetus(Up to 5 days from the birth)