Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
研究概览
简要总结
The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.
详细描述
Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.
Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age > 37 weeks assessed by Last Menstrual Period and dating scan.
- •Women with singleton pregnancy assessed by ultrasound.
- •Fetus in vertex presentation assessed by ultrasound.
- •Age 20-40 years.
- •Bishop score <4.
排除标准
- •Non-consenting.
- •Gestational age < 37 weeks.
- •Patients with history of placenta previa.
- •Patients with history of placental abruption.
- •Ruptured membranes.
- •Patients with history of vaginal infection.
- •Patients with history of congenital anomalies in previous deliveries.
- •Patients with history of stroke, renal impairment and chronic obstructive pulmonary disease, chronic liver disease and congestive cardiac failure
研究组 & 干预措施
M=misoprostol
Patients who would receive Only oral misoprostol{(50 micrograms) tab cytotec ¼ tablets (Searle)}. All patients in this group will be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). If labor is not established within 4 hours of the administration of the fourth dose, induction will be considered to be failed
干预措施: Misoprostol (Drug)
M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER
All patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes).
干预措施: Misoprostol (Drug)
M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER
All patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes).
干预措施: foley's balloon catheter (Device)
结局指标
主要结局
failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
时间窗: six months
次要结局
未报告次要终点
研究者
samia husain
postgraduate trainee
Karachi Medical and Dental College