Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

Conditions
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Induction of Labour With Misoprostol

Intervention / Treatment
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* Drug: Misoprostol Oral Tablet
* Drug: vaginal misoprostol


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral misoprostol<br>oral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given | Drug: Misoprostol Oral Tablet<br>* oral misoprostol 50 microgram repeated after 6 hours if required<br>* Other names: cytotec;|
| Active Comparator: vaginal misoprostol<br>vaginal misoprostol will be given in a dose of 50 microgram and repeated after 6 hours if required.Maximum 2 doses will be given | Drug: vaginal misoprostol<br>* vaginal misoprostol 50 microgram repeated after 6 hours if required<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal birth | vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart | vaginal birth within 24 hours of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesaerean section | cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs | within 24 hours | 
| induction to delivery interval | measured from 1st dose till delivery of patient | within 24 hours | 
| fetal distress | fetal distress measured by non reactive CTG or meconium stained amniotic fluid | within 24 hours | 
| uterine hyperstimulation | more than 5 contractions in every 10 minutes | more than 10 cotractions in every 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labour, misoprostol