Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2023-12-16

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.

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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.

Conditions

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Induction of Labour With Misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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oral misoprostol

oral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given

Group Type EXPERIMENTAL

Misoprostol Oral Tablet

Intervention Type DRUG

oral misoprostol 50 microgram repeated after 6 hours if required

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

Group Type ACTIVE_COMPARATOR

vaginal misoprostol

Intervention Type DRUG

vaginal misoprostol 50 microgram repeated after 6 hours if required

Interventions

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Misoprostol Oral Tablet

oral misoprostol 50 microgram repeated after 6 hours if required

Intervention Type DRUG

vaginal misoprostol

vaginal misoprostol 50 microgram repeated after 6 hours if required

Intervention Type DRUG

Other Intervention Names

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cytotec cytotec

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

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Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes