CTRI/2024/12/078374Not yet recruitingPhase 2
Simultaneous or sequential use of Foley’s catheter and oxytocin for induction of labour -Randomised controlled trial
Dr Swati sharma1 site in 1 country90 target enrollmentStarted: December 29, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- to determine induction to delivery interval and compare it in both groups
Study Overview
Brief Summary
we aim to determine whether simultaneous use of Foley’s and oxytocin will be advantageous to achieve vaginal delivery after IOL without an increase in the oxytocin to delivery interval or the CS rate as compared to sequential use. If found beneficial, it will reduce overnight hospital stay for cervical ripening with Foley’s kept for 12 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Gestational age greater than 34 weeks 2.Bishops score six or less 3.Single live fetus with cephalic presentation 4.Intact membranes 5.Reactive non stress test (NST).
Exclusion Criteria
- •1.Previous uterine scar (caesarean section or myomectomy) 2.Parity greater than 3 3.Fetal congenital malformations 4.Severe fetal growth restriction(estimated fetal weight less than 3rd centile and/or abnormal Doppler changes in umbilical artery ) 5.Pre-eclampsia with severe features /eclampsia 6.Antepartum haemorrhage 7.Premature rupture of membranes (PROM) 8.Cervicovaginal infections 9.Medical disorders (heart disease, seizure disorder, severe anaemia, renal disease, uncontrolled diabetes, uncontrolled hypertension, retropositive status).
Outcomes
Primary Outcomes
to determine induction to delivery interval and compare it in both groups
Time Frame: 11 months
Secondary Outcomes
- 1. Caesarean section (CS) rate 2. Incidence of uterine contraction abnormalities 3. Infectious morbidity in the mother (chorioamnionitis or puerperal sepsis) 4. Composite Neonatal outcome(11 months)
Investigators
Dr Swati sharma
PGIMER Chandigarh
Study Sites (1)
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