Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time from induction to delivery
研究概览
简要总结
The objective of this interventional study is to compare the effectiveness, safety, and patient satisfaction associated with two commonly used methods of labor induction: low-dose oral misoprostol and the vaginal delivery system with dinoprostone.
The study aims to identify the most suitable induction method for specific subgroups of patients based on parity, body mass index (BMI), age, and cervical ripeness, as well as assess patient preferences for these induction methods.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 37 0/7 and 42 0/7 weeks
- •Singleton pregnancy
- •Viable fetus in cephalic presentation
- •Bishop score ≤ 6
- •Maximum parity of three
- •Reactive CTG at admission without pathological findings
排除标准
- •Age < 18 years
- •Gestational age < 37 0/7 weeks
- •Active labor
- •Spontaneous rupture of membranes
- •Non-reassuring CTG findings
- •Suspected infection (e.g., fever > 38°C, chorioamnionitis, or unexplained systemic infection)
- •Contraindications to vaginal delivery or prostaglandin use
- •Previous cesarean delivery or uterine surgery involving entry into the uterine cavity
- •Significant fetal abnormalities
- •Severe fetal growth restriction with an estimated fetal weight below the 3rd percentile
- •Non-Slovenian-speaking participants
研究组 & 干预措施
Group undergoing labor induction with the dinoprostone vaginal delivery system
Pregnant women in this group will receive a vaginal delivery system containing 10 mg of dinoprostone for labor induction. The medication will be inserted into the posterior fornix of the vagina, with the active substance being released over a 24-hour period. Maternal and fetal health will be monitored during their stay on the ward. Upon the onset of contractions or any signs of fetal distress, patients will be transferred to the delivery unit. If labor does not commence and the cervix remains unfavorable after 24 hours, a new vaginal delivery system will be inserted for an additional 24 hours. If no progress is observed within 48 hours of induction, a mechanical method for labor induction or cesarean delivery will be employed. After delivery, women will complete a questionnaire to assess their satisfaction with the childbirth experience.
干预措施: dinoprostone vaginal delivery system (Drug)
Group undergoing labor induction with the low dose peroral misoprostol
Participants will be induced with a low-dose oral formulation of misoprostol, administered per protocol at 25 mcg every 2 hours until adequate uterine contractions and a favorable cervical condition are achieved. A maximum of 8 doses will be administered on the first day. If labor does not commence and the cervix remains unfavorable, a second induction cycle will be initiated the following day. If no progress occurrs after 48 hours from the induction, participants will undergo cesarean delivery, or alternative mechanical induction method will be used. Following delivery, participants will complete a questionnaire to assess their satisfaction with the childbirth experience.
干预措施: low dose peroral misoprostol (Drug)
结局指标
主要结局
Time from induction to delivery
时间窗: 1 week from induction
The time from the insertion of the vaginal delivery system or administration of the oral tablet to the time of delivery
次要结局
- Time from induction to spontaneos vaginal delivery(1 week from induction)
- Time from induction to onset of active labour(1 week from induction)
- Use of oxytocin and its dosage(1 week from induction)
- Use of analgesia during labour(1 week from induction)
- Type of delivery(1 week from induction)
- Number of participants with fourth degree tear of perineum during labour(1 week from induction)
- Hyperstimulation with nonreassuring fetal heart rate tracing(1 week from induction)
- Duration of labour(1 week from induction)
- Postpartum hemorrhage above 1000 mL(1 week from induction)
- Number of participants with third degree tear of perineum during labour(1 week from induction)
- Side effects of misoprostol and dinoprostone(1 week from induction)
- Number of newborns wtih 5-minute APGAR score of less than 7(1 week from induction)
- pH from umbilical artery(1 week from induction)
- Number of newborns admitted to intensive care unit(3 weeks from induction)
- Satisfaction with induction(1 week from induction)
- Satisfaction with childbirth(3 weeks from induction)