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临床试验/NCT06343480
NCT06343480已完成不适用

Sublingual Misoprostol Versus Oxytocin Titration for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term: A Randomised Controlled Tial.

Federal Teaching Hospital Abakaliki2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Mean induction delivery interval

研究概览

简要总结

Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.

详细描述

Induction of labour for term premature rupture of fetal membranes (PROM) is associated with greater maternal satisfaction and lower risk of maternal infection compared with expectant management. The ideal method of induction of labour for term PROM is a subject of controversy. Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.

This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term PROM. This was a double blind randomized controlled trial on the efficacy of sublingual misoprostol versus oxytocin titration in women with term PROM at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and Mile 4 Hospital Abakaliki. 240 Participants were divided into two groups of 120 participants each. Group A received 25 mcg of sublingual misoprostol and titration of 500 ml of Ringer's lactate solution as placebo with 5ml of sterile water injected into it while group B underwent immediate induction of labour with titration of 5 units of oxytocin in a 500 ml of Ringer's lactate solution and received one tablet of 100mg Vitamin C as placebo. The primary outcome measure was the mean induction delivery interval. The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers and percentages. Categorical variables were analyzed using Chi-square while means were compared using T-test. A difference with a P value of <0.05 was considered significant.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • signed informed consent
  • singleton pregnancy at term
  • prelabour rupture of membranes
  • not having contraction
  • Bishop scoe 5 or less

排除标准

  • prelabour rupture of membranes at less than term
  • declined consent
  • contraindication for vaginal delivery
  • multiple gestation
  • medical conditions co-existing with pregnancy
  • grand multiparous parturients
  • previous caesarean section scar
  • already having contractions
  • has intrauterine foetal death
  • bishop sore >5

研究组 & 干预措施

first arm - Oxytocin titration

Active Comparator

Received vitamin c 100mg as placebo and had Oxytocin titration in 500ml of ringers lactate for labour induction

干预措施: Labour Induction (Drug)

second arm - Misoprostol give sublingual

Active Comparator

received 25mcg of Misoprostol and titration of plane 500ml of ringers lactate as placebo

干预措施: Labour Induction (Drug)

结局指标

主要结局

Mean induction delivery interval

时间窗: During the delivery

the time take from start of induction to the time of delivery of the fetus.

次要结局

未报告次要终点

研究者

发起方
Federal Teaching Hospital Abakaliki
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nwali Matthew Igwe

Principal Investigator

Federal Teaching Hospital Abakaliki

研究点 (2)

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