The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor
试验速览
- 阶段
- 3 期
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- duration of first stage of labour
研究概览
简要总结
The effect of coadministration of oral propranolol to oxytocin on induction of labor.
详细描述
Study hypothesis:
Oral propranolol when used with oxytocin during the process of labor may reduce labor interval and decrease the rate of cesarean delivery.
Study population:
The patients will be recruited from the women attending obstetrics reception room, in Ain Shams University Maternity Hospital.
Intervention:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age above 37 weeks.
- •Fetal life positive on ultrasound.
- •Bishop score >
- •Primiparous women.
排除标准
- •history of uterine surgery
- •polyhydramnios
- •contraindications to β-adrenergic agents, such as systolic blood pressure less than 100 mmHg or pulse rate less than 60/min and more than 120/min
- •history of any known cardiac disease
- •mother's pulmonary or metabolic disorders
- •fetal distress
- •estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation
研究组 & 干预措施
propranolol plus oxytocin
121 patients who will receive a capsule containing 20 mg propranolol (propranolol plus oxytocin) administrated orally before beginning induction and repeated after 8 hours if no sufficient uterine contractions reached.
干预措施: propranolol (Drug)
propranolol plus oxytocin
121 patients who will receive a capsule containing 20 mg propranolol (propranolol plus oxytocin) administrated orally before beginning induction and repeated after 8 hours if no sufficient uterine contractions reached.
干预措施: Oxytocin (Drug)
placebo plus oxytocin
121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.
干预措施: placebo (Drug)
placebo plus oxytocin
121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.
干预措施: Oxytocin (Drug)
结局指标
主要结局
duration of first stage of labour
时间窗: 24 hours
duration of first stage of labour in hours
次要结局
- rate of cesarean section(48 hours)
- Apgar score(24 hours)
研究者
Amr Ahmed Mahmoud Riad
Lecturer of obstetrics and gynecology
Ain Shams Maternity Hospital