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