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临床试验/CTRI/2019/08/020657
CTRI/2019/08/020657尚未招募1 期

: Randomised placebo controlled trial to compare maternal and fetal effects following discontinuation VERSUS continuation of oxytocin in active labour

FLUID GRANT INSTITUTIONAL1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年8月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
600
试验地点
1
主要终点
Overall LSCS rate

研究概览

简要总结

Induction of labour is a common obstetric procedure. It aims at stimulating  labour using artificial methods with the aim to achieve delivery in women with complications

such as hypertension ,  diabetes  , fetal growth restriction etc. The most common pharmacological agent being used for this is oxytocin.

While oxytocin is safe and effective  in most cases, it may cause uterine  hyperstimulation leading to fetal distress and warranting LSCS. Women with prolonged use of oxytocin also may sometimes have complications like post partum haemorrhage or chorioamnionitis.

 The aim of the study is compare the maternal and fetal outcomes in two groups of women who undergo induction of labour when they are managed with two different labour protocols. In Group I ,  oxytocin will be  stopped once woman enters into active stage or when cervix is >5 cm dilated  .  Oxytocin will not be given till delivery unless the woman has slow progress in labour or fails to get regular uterine contractions

 In Group II,  Oxytocin will be continued till delivery . Vaginal examinations will be done every four hours or earlier if there are cases of fetal distress .The primary outcome

will be to compare LSCS rates in both groups. Our hypothesis is that there should be a decrease in LSCS rate by  10% in the intervention arm (Group 1) where oxytocin is being stopped iin active phase of induced labour.

Secondary maternal outcomes  will be to compare the duration of labour  along with rates of postpartum haemorrhage ; uterine hyperstimulation;  and chorioamnionitis. Neonatal outcomes will be to look at rates of fetal heart rate abnormalities as documented

on CTG (cardiotocograph); ; Apgar score at 5mins; need for Neonatal Intensive care (NICU) admission

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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

  • All pregnant women with singleton pregnancies undergoing labour induction at term.

排除标准

  • Multiple pregnancy preterm Previous LSCS Severe pre eclampsia/gestational hypertension abruption meconium stained amniotic fluid.

结局指标

主要结局

Overall LSCS rate

时间窗: AT THE END OF THE PREGNANCY (37-41 WEEKS )

次要结局

  • Maternal:(Mean duration of labour, Number of women in Discontinuation group who were restarted back on Oxytocin,Number of women in Continuation group where oxytocin was stopped, Uterine hyperstimulation, Post-partum haemorrhage, Chorioamnionitis, Breast feeding)

研究者

发起方
FLUID GRANT INSTITUTIONAL
申办方类型
Research institution and hospital

研究点 (1)

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