Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
- Conditions
- Induction of Labour With Misoprostol
- Interventions
- Registration Number
- NCT05957666
- Lead Sponsor
- Services Institute of Medical Sciences, Pakistan
- Brief Summary
A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.
- Detailed Description
The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023.
Total 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 176
Cephalic presentation Prelabour rupture of membranes Singleton pregnancies reaching 41 weeks G1 to G4 Bishop score of less than or equal to 6 Medical disorders(GDM,PIH) -
Previous uterine scar Antepartum hemorrhage Cephalopelvic disproportion Multiple gestation Multiparity Oligohydramnios/polyhydramnios IUGR Severe systemic illness like pre eclampsia,eclampsia,cardiac,hepatic,renal disease PPROM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vaginal misoprostol vaginal misoprostol vaginal misoprostol will be given in a dose of 50 microgram and repeated after 6 hours if required.Maximum 2 doses will be given oral misoprostol Misoprostol Oral Tablet oral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given
- Primary Outcome Measures
Name Time Method vaginal birth vaginal birth within 24 hours of admission vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart
- Secondary Outcome Measures
Name Time Method induction to delivery interval within 24 hours measured from 1st dose till delivery of patient
cesaerean section within 24 hours cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs
fetal distress within 24 hours fetal distress measured by non reactive CTG or meconium stained amniotic fluid
uterine hyperstimulation more than 10 cotractions in every 10 minutes more than 5 contractions in every 10 minutes
Trial Locations
- Locations (1)
Services Institute Of Medical Sciences
🇵🇰Lahore, Punjab, Pakistan