Induction of Labour With Misoprostol
Conditions
Keywords
induction of labour, misoprostol
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.
Interventions
oral misoprostol 50 microgram repeated after 6 hours if required
DRUGvaginal misoprostol
vaginal misoprostol 50 microgram repeated after 6 hours if required
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
patients will either recieve oral or vaginal misoprostol by envelope method ina dose of 50microgram.Total of 176 envelopes are placed in a concealed box.Neither the doctor nor the patient knows.
Intervention model description
Total 176 patient included in this study.Patients will be randomised by envelop method to recieve either oral or vaginal misoprostol in a dose of 50microgram.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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) -
Exclusion criteria
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| cesaerean section | within 24 hours | cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs |
| induction to delivery interval | within 24 hours | measured from 1st dose till delivery of patient |
| 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 |
Countries
Pakistan
Contacts
Primary ContactTayyiba Wasim, FCPS
Backup ContactKalsoom Waheed, FCPS
Outcome results
None listed