A Comparison Between the Effect of Oxytocin Only and Oxytocin Plus Propranolol on Induction of Labor in Term Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Time from active phase to delivery in minutes
研究概览
简要总结
The present study is conducted to compare the effect of Oral Propranolol and Oxytocin, versus Oxytocin only on induction of labor in term pregnancy.
详细描述
After receiving approval from the Hospital Ethics Committee, women with uncomplicated term pregnancy who will be admitted to the Ainshams maternity hospital will be recruited in this study.
Inclusion criteria:
- Gestational age of 38-41 weeks of pregnancy (according to a reliable last menstrual period (LMP) and sonography of first trimester)
- Nulliparity,
- Singleton pregnancy.
- Cephalic presentation.
- Intact membranes.
- Bishop Score 5 or more.
Exclusive criteria:
- Pelvic contraction,
- Previous surgical operation on the uterus,
- Signs of fetal distress,
- Placenta previa
- Suspicious macrosomia,
- Polyhydramnios,
- Hydrocephalus of fetus
- History of any known cardiac, pulmonary or metabolic disorder of mother, or maternal drug use.
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, Investigator)
盲法说明
Then Patients will be randomly assigned to two groups using sealed, sequentially distributed envelopes to which the letters A and B will be allocated. The letter A will be assigned to the propranolol group and the letters B to the oxytocin group. The envelopes, will be opened by the investigator, and according to the letters, the group of patients will be determined. The first vaginal examination will be performed by the investigator, and then the induction will be initiated by the same researcher. Continuation of induction and the control of patients will be monitored by a coworker who knew nothing about the method of initiation of induction, neither did the patients (double blind)
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of 38-41 weeks of pregnancy (according to a reliable last menstrual period (LMP) and sonography of first trimester)
- •Nulliparity,
- •Singleton pregnancy.
- •Cephalic presentation.
- •Intact membranes.
- •Bishop Score 5 or more.
排除标准
- •Pelvic contraction,
- •Previous surgical operation on the uterus,
- •Signs of fetal distress,
- •Placenta previa
- •Suspicious macrosomia,
- •Polyhydramnios,
- •Hydrocephalus of fetus
- •History of any known cardiac, pulmonary or metabolic disorder of mother, or maternal drug use.
研究组 & 干预措施
Propranolol
101 women with uncomplicated term pregnancy who will be admitted to the Ain Shams University Maternity hospital and will receive syntocinon intravenous infusion for induction or augmentation of labour.
干预措施: Propranolol (Drug)
placebo
101 women with uncomplicated term pregnancy who will be admitted to the Ain Shams University Maternity hospital and will receive syntocinon intravenous infusion for induction or augmentation of labour.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Time from active phase to delivery in minutes
时间窗: 16 hours
Time from active phase to delivery in minutes
次要结局
未报告次要终点
研究者
Amr Ahmed Mahmoud Riad
lecturer of obstetrics and gynecology
Ain Shams Maternity Hospital