Study to see if discontinuation of oxytocin in active phase of induced labours has an effect on the maternal and fetal outcomes.

Phase 1

Not yet recruiting

Conditions: Pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2019/08/020657

Lead Sponsor: FLUID GRANT INSTITUTIONAL

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall LSCS rate	AT THE END OF THE PREGNANCY (37-41 WEEKS )

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): CHRISTIAN MEDICAL COLLEGE
🇮🇳
Vellore, TAMIL NADU, India
CHRISTIAN MEDICAL COLLEGE
🇮🇳Vellore, TAMIL NADU, India
Dr Mrudul Shinge
Principal investigator
9822451887
mrudul.shinge@gmail.com