Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Time to Delivery
研究概览
简要总结
The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are:
- Does a high dose oxytocin infusion protocol affect length of induction to delivery interval?
- Does a high dose oxytocin infusion protocol affect mode of delivery?
- Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes?
Participants will be randomized to either low- or high-dose oxytocin groups:
- The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min.
- The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-50 years old
- •Singleton gestation
- •Nulliparous
- •Vertex presentation
- •Gestational age greater than or equal to 37 weeks
- •No prior uterine surgery
- •Presents for elective or medically indicated induction of labor
- •Need for augmentation of labor with oxytocin
排除标准
- •Previous cervical ripening using non-mechanical methods
- •Patient unable or unwilling to provide verbal consent
- •Contraindications to vaginal delivery
- •Fetal demise or life-limiting anomaly
- •Allergy to oxytocin
- •Non-reassuring fetal heart tracing prior to inclusion
- •Maternal pulmonary edema prior to inclusion
- •Fetal growth restriction
研究组 & 干预措施
High dose oxytocin
The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
干预措施: Oxytocin (High dose) (Drug)
Low dose oxytocin
The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
干预措施: Oxytocin (Low dose) (Drug)
结局指标
主要结局
Time to Delivery
时间窗: Through delivery, on average 24 hours
Induction to delivery time interval
次要结局
- Mode of Delivery(Through delivery, on average 24 hours)
- Rate of Primary Cesarean Delivery(Through delivery, on average 24 hours)
- Maximum Dose of Oxytocin Infusion(Through delivery, on average 24 hours)
- Rate of Uterine Tachysystole(Through delivery, on average 24 hours)
- Number of Participants With Postpartum Hemorrhage(From delivery through the postpartum period (average duration approximately 24 hours))
- Rate of Placental Abruption(Through delivery, on average 24 hours)
- Number of Participants With Nausea/Vomiting Requiring Antiemetics and Diarrhea(From delivery (average duration approximately 24 hours))
- Rate of Maternal Infection (Endometritis, Chorioamnionitis)(Through delivery, on average 24 hours)
- Rate of Serious Maternal Morbidity and Mortality(Through delivery, on average 24 hours)
- Number of Neonates With One or More of: Perinatal Death, Severe Respiratory Distress Requiring Ventilation, Neonatal Encephalopathy, Neonatal Seizure, Neonatal Sepsis, 5-minute APGAR Score <7, Umbilical Artery Acidemia, Neonatal ICU Admission(From birth through 24 hours)
- Number of Participants With Neonatal Sepsis (Confirmed With Cultures)(From birth through 24 hours)
- Rate of Umbilical Artery Acidemia (Base Excess <12)(Through delivery, on average 24 hours)