The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- changes in labour-associated maternal and fetal hormone levels
研究概览
简要总结
Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section.
Design- Participants were randomized to undergo induction of labour by breast stimulation or intracervical balloon compared to spontaneous labour (controls).
Setting- A single tertiary hospital Population- women at term, with previous caesarean section
详细描述
Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including the two groups catheter balloon and breast stimulation and controls in spontaneous labor. Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical outcomes were documented in the two induction groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •uncomplicated pregnancy
- •37-42 weeks of pregnancy
- •singleton pregnancy
- •cephalic presentation
- •previous one low transverse cesarean section
- •indicated induction of labour
排除标准
- •fetal anomaly
- •past uterine rupture
- •previous preterm cesarean section
- •multiple pregnancy
- •polyhydramnios
- •any contraindication for vaginal delivery or catheter balloon insertion
研究组 & 干预措施
induction of labour by breast stimulation
women at term with previous cesarean section and an indication to induce labor. In order to induce labour by breast stimulation, an electrical pump was used. The cup was alternated between the nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes, with a total induction time of 6 hours.
干预措施: induction of labor by breast stimulation (Device)
induction of labour by catheter balloon
women at term with previous cesarean section and an indication to induce labor. In the catheter balloon group, a 16-F Foley catheter was inserted into the cervical canal and inflated with 60 cc sterile saline solution and was kept in place for 12 hours.
干预措施: induction of labor by catheter balloon (Device)
spontaneous labour
women in latent phase of spontaneous labour .
结局指标
主要结局
changes in labour-associated maternal and fetal hormone levels
时间窗: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: oxytocin (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
次要结局
- To compare efficacy and safety of labour induction methods in women with previous caesarean section(at birth)
研究者
Dr. Maya Wolf
Head of fetal-maternal unit
Western Galilee Hospital-Nahariya