Efficacy and Safety of Sublingual Versus Vaginal Misoprostol for Induction of Labor for Primigravida at 41 or More Weeks of Pregnancy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To measure the number of pregnant mothers who have a vaginal delivery within 24 hours of the induction.
研究概览
简要总结
This research is to compare the efficacy and the safety of sublingual misoprostol with vaginal misoprostol administration for the induction of labour for primigravida at 41 or more weeks of pregnancy. In routine practice, misoprostol 25µg is used by per vaginal route for the induction of labour in Bhutan. The misoprostol dose is given repeatedly every 4 hours to a maximum of 6 dosages. The per vaginal route is found to be very effective and safe for the induction of labour. But, patient compliance is poor and increasing the risk of neonatal sepsis since it has to be inserted into vagina every 4 hours. To overcome these problems with per vaginal route, this study is developed to explore the efficacy and safety of misoprostol use by sublingual routes for the induction of labour. Misoprostol can be used by sublingual, oral or per vaginal route as per the findings of the other studies.
If the finding of this study proves sublingual use of misoprostol is safe and efficient for the induction of labour, the current practice of using misoprostol by vaginal route will be changed to sublingual route in Bhutan.
详细描述
Induction of labour is an intervention intended to artificially initiate uterine contraction in pregnant women who are not in labour. It is a common practice to interrupt the pregnancy at 41 weeks of gestation and deliver the fetus when continuation of pregnancy is no longer considered safe.
The methods of induction can be non-pharmacological or pharmacological. Prostaglandins and oxytocin are the commonly used drugs for induction of labour.
Prostaglandins are the current drug of choice and have been used for labour induction in pregnant women with an unfavourable cervix. Misoprostol is a synthetic analogue of prostaglandin E1 and it has been extensively and successfully used for labour induction due to its efficacy, low cost and stability at room temperature. Misoprostol can be used by oral, vaginal or sublingual routes for the labour induction. Among which vaginal misoprostol has been extensively used and shown to be an effective method of induction of labour. Sublingual route of misoprostol is equally safe and effective for induction of labour. In fact, sublingual route of misoprostol administration is found to be more effective in induction of labour as compared to vaginal route. This sublingual route is appealing for several reasons, including the convenience, easy to administer and a higher patient's acceptability. In contrast to per vaginal misoprostol administration, sublingual route avoids repeated per vaginal examination which is a risk factor for neonatal sepsis.
In Bhutan per vaginal misoprostol is being extensively used for induction of labour by the Gynecologists. The neonatal sepsis rate is 19 per 1000 in Bhutan, which is the highest in Asia. The high rate of neonatal sepsis in Bhutan is found to be associated with repeated vaginal examination done during pregnancy to administer misoprostol dose.
No study has been conducted in Bhutan to find out the safety and efficacy of per vaginal misoprostol use nor is there any study on sublingual use of misoprostol for the induction of labour.
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 (Outcomes Assessor)
盲法说明
The participants and the investigators will not be masked; however, outcome assessor (statisticians) will be masked because they will not know anything about the drugs received by sublingual or per vaginal routes as their role will be to analyze the outcome only.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or more years
- •Primigravida
- •Singleton pregnancy
- •Gestation at 41 or more weeks of pregnancy
- •Estimated fetal weight of <4000 gram
- •In cephalic presentation
- •Bishop score < 6 (unfavorable cervix)
- •Reassuring fetal heart rate tracing
排除标准
- •Age <18 years
- •Multiple pregnancy (twin, triplet and higher order pregnancies)
- •Gestation <41 weeks of pregnancy
- •Fetal macrosomia (Estimated fetal weight >4000 gram)
- •Cephalo-pelvic disproportion
- •Malpresentation (breech, oblique, transverse)
- •Bishop score >6 (favorable cervix)
- •Presence of labor or uterine contractions
- •Non-reassuring fetal heart rate tracing
- •Pregnant women with known allergy to misoprostol,
- •Previous Caesarean delivery or other uterine surgery
- •Previous uterine rupture
- •Placenta previa
- •Chorioamnionitis
- •Prelabour rupture of membrane (PROM)
- •Antepartum hemorrhage (per vaginal bleeding)
- •Contraindication to vaginal birth
- •Medical disorders in pregnancy
- •Active genital herpes infection
- •Invasive cervical carcinoma
研究组 & 干预措施
Sublingual misoprostol
Sublingual misoprostol group will receive misoprostol 25µg by sublingual routes; the dose will be given repeatedly every 4 hours by sublingual route till there is labour pain or contraction or to a maximum of 6 dosages.
干预措施: Misoprostol (Drug)
Vaginal misoprostol
Vaginal misoprostol group will receive misoprostol 25µg by per vaginal routes; the dose will be given repeatedly every 4 hours by per vaginal route till there is labour pain or contraction or to a maximum of 6 dosages.
干预措施: Misoprostol (Drug)
结局指标
主要结局
To measure the number of pregnant mothers who have a vaginal delivery within 24 hours of the induction.
时间窗: The numbers of successful vaginal delivery conducted in each group will be measured for 6 months.
The number of successful vaginal deliveries will be recorded and compared between the study arms. This is to study the overall efficacy of sublingual use of misoprostol in compared between the study group
次要结局
- To compare the dosages of misoprostol required for induction of labour in the study arms.(The total number of repeat dosages of misoprostol use in the each study participant will be determined for 24 hours.)
- The modes of delivery will be compared between the study arms(The individual modes of delivery will be documented for 24-48 hours)
- To compare the induction to delivery interval between the study group(The time taken from the starting of the induction to the time at delivery will be measured for individual study participant for 24 - 48 hours.)
研究者
Yeshey Dorjey
Principal Investigator
Ministry of Health, Bhutan