High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- The mean duration from oxytocin augmentation initiation to delivery
研究概览
简要总结
Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Spontaneous onset of labor.
- •Body mass index ≥ 30 kg/m
- •Gestational age ≥ 37 weeks.
- •Singleton pregnancy.
- •Cephalic presentation.
- •Reassuring fetal heart rate monitoring.
- •Inefficient uterine contractions during active labor
- •Women who will accept to participate in the study.
排除标准
- •Non-reassuring fetal assessment at the time of recruitment.
- •Women received cervical ripening agents.
- •Any patients contraindicated for vaginal delivery.
- •Multiple gestations.
- •Malpresentation.
- •Previous cesarean delivery.
- •Patients with cardiac diseases, pre-eclampsia or any other medical disorders.
- •Fetal demise.
- •Intrauterine growth restriction.
- •Estimated fetal weight ≥ 5000 grams.
- •Pre-labor rupture of membranes > 24 hours.
研究组 & 干预措施
low dose oxytocin
patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 2 mU/min, incrementally increase by 2 mU/min every 30 minutes until achievement of adequate uterine contractions.
干预措施: Oxytocin (Drug)
high dose oxytocin
patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 4 mU/min, incrementally increase by 4 mU/min every 30 minutes until achievement of adequate uterine contractions
干预措施: Oxytocin (Drug)
结局指标
主要结局
The mean duration from oxytocin augmentation initiation to delivery
时间窗: 12 hours
the calculated time between oxytocin infusion till delivery
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University