跳至主要内容
临床试验/CTRI/2021/02/031241
CTRI/2021/02/031241尚未招募不适用

Study Of Immediate Induction Of Labor With Cerviprime gel and Delayed Induction Of Labor With Oxytocin at Term Prelabor Rupture Of Membranes

Parkuru monica1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To determine whether early induction with intravaginal cerviprime

研究概览

简要总结

·         Antenatal women at term with prelabor rupture of membranes with amniotic fluid leak from cervical os is confirmed  by sterile per speculum examination under aseptic conditions are included in study after taking history and written informed consent.

·         Prophylactic antibiotics will be administered and nonstress test will be performed to know fetal wellbeing.

·         Amount of liquor will be assessed by ultrasonography.

·         The antenatal women who are not in labor are  divided into two groups by Modified bishop’s score. Patients who are fulfilling inclusion criteria are selected and seggregated into two groups after counselling, based on their will.

·         In group A, they will be induced immediately within 6hours of prelabor rupture of membranes with intravaginal instillation of 0.5mg Prostaglandin E2 gel into posterior fornix. If bishop’s score doesnot improve after 6hours then application of  Prostaglandin E2 gel is repeated maximum of two doses. After two doses of Prostaglandin E2 gel, labor augmentation will be done with oxytocin.

·         In group B, the patients included are those with prelabor rupture of membranes with duration morethan or equal to 6 hours. They will be observed for 12hours for spontaneous onset of labor, if patient fails then induction or augmentation with intravenous oxytocin drip is started, 5U in 500ml ringer lactate solution in primigravida and 2.5U in 500ml ringer lactate solution in multiparous women with infusion rate of 4 drops per min. The rate of infusion is doubled every 20mins until the occurrence of  4 contractions lasting for 45 seconds in 10mins, upto maximum infusion rate of 32mIU/min.

·         Both groups are closely monitored by:

Temperature recording 4th hourly.

Maternal tachycardia.

Uterine contractions.

Fetal heartrate auscultation every 30mins.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Singleton fetus with cephalic presentation.
  • Gestational age between 37-40 weeks.
  • Spontaneous rupture of membranes confirmed by history and examination.
  • Primi or multigravida.
  • Absent or mild uterine contractions (1-2 contractions lasting for 10-15 seconds).
  • Viable fetus.
  • Modified Bishop’s score <6.

排除标准

  • Multiple gestation.
  • Fetal Malpresentation.
  • Cephalopelvic disproportion.
  • Previous cesarean section or major uterine surgery.
  • Medical and Obstetric complications (Preeclampsia, Diabetes, Heart disease complicating Pregnancy, Placenta previa.) Active labor.
  • Oligohydramnios (with IUGR, not due to prelabor rupture of membranes) Evidence of fetal distress.
  • Meconium stained liquor.
  • Chorioamnionitis.
  • Cord prolapse.
  • Preterm prelabor rupture of membranes.

结局指标

主要结局

To determine whether early induction with intravaginal cerviprime

时间窗: To determine whether early induction with intravaginal cerviprime | gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is | preferable in prelabor rupture of membranes at term.

gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is

时间窗: To determine whether early induction with intravaginal cerviprime | gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is | preferable in prelabor rupture of membranes at term.

preferable in prelabor rupture of membranes at term.

时间窗: To determine whether early induction with intravaginal cerviprime | gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is | preferable in prelabor rupture of membranes at term.

次要结局

未报告次要终点

研究者

发起方
Parkuru monica
申办方类型
Research institution and hospital

研究点 (1)

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