The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Rate of Cesarean section in labor
研究概览
简要总结
This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). The intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (CS) in first time mothers at term (≥ 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. If REDUCE-I pilot trial suggests a safe reduction in CS rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.
详细描述
This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. The intervention will take place at Foothills Medical Centre (FMC). Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. Participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. Once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the Alberta Health Services Research Pharmacy). Treatment period will continue until delivery. If the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted.
Royal Alexandra Hospital in Edmonton will be used as a contemporaneous non-intervention control site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Once a patient is found to be ≥6 cm dilation, the study medication will be initiated. Pharmacy will make up identical vials of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician. Nurses will use the blinded vials for ongoing infusion. Patients and caregivers will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women undergoing induction of labor with oxytocin.
- •Primiparous
- •18 years old or older
- •at term (≥37 weeks)
- •cephalic presenting
- •singleton fetus
排除标准
- •Multiple pregnancies
- •known fetal congenital or chromosomal anomalies
研究组 & 干预措施
Intervention site (Foothills Medical Centre): Continuation of Oxytocin
Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be >= 6 cm dilated.
干预措施: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). (Drug)
Intervention site (Foothills Medical Centre): Discontinuation of oxytocin
Participants in this arm will receive a blinded vial of saline solution once a patient is found to be >= 6 cm dilated.
干预措施: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). (Drug)
结局指标
主要结局
Rate of Cesarean section in labor
时间窗: At Delivery
Rate of Cesarean section in labor
Occurrence of Uterine Hyperstimulation
时间窗: During labour, after >=6 cm dilation
Occurrence of \>5 contractions in 10 minutes
Proportion of screened subjects who agree to enroll in the trial
时间窗: During screening of potential participants
Proportion of screened subjects who agree to enroll in the trial
次要结局
- Rate of postpartum hemorrhage(At delivery)
- Rate of postpartum uterine artery/pelvic artery embolization(Within 28 days of delivery)
- Rate of postpartum hysterectomy(Within 28 days of delivery)
- Rate of postpartum maternal intensive care unit (ICU) admission(At delivery)
- Rate of perinatal death(At delivery)
- Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling(At delivery)
- Rate of neonatal asphyxia(At delivery)
- Rate of neonatal sepsis or suspected sepsis(At delivery)
- Rate of blood transfusion(At delivery)
研究者
Stephen Wood
Professor
University of Calgary