Clinical trial NCT05957666: Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
Official title: Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Induction of Labour With Misoprostol
Keywords: induction of labour
misoprostol
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2023-07-24
Enrollment: 176
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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Primary outcomes:
measure: vaginal birth
timeFrame: vaginal birth within 24 hours of admission
Secondary outcomes:
measure: cesaerean section
timeFrame: within 24 hours
measure: induction to delivery interval
timeFrame: within 24 hours
measure: fetal distress
timeFrame: within 24 hours
measure: uterine hyperstimulation
timeFrame: more than 10 cotractions in every 10 minutes
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute Of Medical Sciences
state: Punjab
Study officials:
References: