Vaginal misoprostol compared to sublingual misoprostol in induction of labor in singleton primigravidae with premature rupture of membranes at gestational age of 36 weeks or later-A Double blinded, Randomized control, Superiority trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 290
- 试验地点
- 1
研究概览
简要总结
The sublingual route of administration
leads to higher peak plasma levels and increased
bioavailability compared to the vaginal route.
However, plasma levels remain elevated for longer
durations when administered vaginally. In one of the
studies, sublingual group experienced nearly double
the occurrence of uterine hyperstimulation, late fetal
heart rate (FHR) decelerations during labor and
Caesarean deliveries compared to vaginal group. 3
This study is aimed at comparing the safety and
efficacy of sublingual with that of vaginal
administration of misoprostol for labor induction in
women carrying a live, full-term fetus with PROM
Novelty-This is one of the few studies worldwide,
comparing sublingual versus vaginal misoprostol in
singleton primigravida with PROM
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.More than 18years of age 2.Bishop score of less than or equal to 4 3.Unscarred uterus.
排除标准
- •1.BMI >40 2.Allergic to prostaglandin 3.Antepartum haemorrhage 4.Foetal distress before induction process as revealed by Non stress test 5.Cephalo pelvic disproportion(CPD) 6.Meconium stained liquour at admission.
研究者
Dr Hastha R Aithal
JIPMER