Efficacy of early versus expectant artificial rupture of membranes in reducing induction delivery interval following cervical ripening by combined misoprostol and mechanical method : a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- time to delivery (hours)
研究概览
简要总结
Patients will be enrolled in the study according to inclusion and exclusion criteria.Patients with singleton pregnancy, cephalic presentation with informed written consent, needing induction of labour at or after 37 weeks of gestation will be included.Patient with known previous scar,fetal demise ,fetal congenital anomaly ,with HIV or Hepatitis infection or category 3 fetal heart tracing or not giving consent will be excluded.
Eligible patients [n=66] will be randomized into 2 groups , Group A (Early artificial rupture of membranes) and Group B (Expectant artificial rupture of membranes).Randomization will be done by sequentially numbered opaque sealed envelope technique.All patients in this trial will undergo combination of intracervical foley catheter insertion and misoprostol for induction of labour.Foley catheter will be placed above the level of internal is and inflated with 40 cc sterile water.In addition,1 misoprostol tab 25 microgram will be placed high into posterior vaginal fornix at the time of foley catheter insertion.Subsequent doses will be repeated every 4 hours upto 5 additional doses or a maximum of 24 hours.
In group A (Early artificial rupture of membranes),[n=33], artificial rupture of membranes will be done immediately after intracervical foley catheter expulsion
In group B (Expectant artificial rupture of membranes) ,[n=33],artificial rupture of membranes will be done after 4 hours of intracervical foley catheter expulsion .
Post foley catheter expulsion,if the bishop score is poor(8) then we will continue further induction with oxytocin .Fetomaternal surveillance will be done throughout induction,labor and delivery.
Time to delivery (hours) [defined as the time from start of induction to delivery] will be assessed as primary outcome.
Secondary outcome measures will include time to active labor (defined as Cervical dilatation as 6 cm), cesarean delivery rate, number of neonates requiring NNU/NICU admission
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Individuals aged 18 or above Patients who need induction of laborAt or37 0 7 weeks of gestation Singleton pregnancy Cephalic presentation Women giving written informed consent will be taken.
排除标准
- •Known Previous uterine scar fetal demise known major fetal congenital anomaly HIV infection, or hepatitis C before the start of labor induction Premature rupture of membranes, preterm premature rupture of membranes patient not giving consent Category 3 fetal heart rate tracing,hemolysis, elevated liver enzymes, and low platelets syndrome or eclampsia; growth restriction 10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler; or growth restriction.
结局指标
主要结局
time to delivery (hours)
时间窗: time from start of induction to | delivery,
次要结局
- time to active labor(Cesarean delivery rate)
研究者
Arti Verma
King Georges Medical University Lucknow