Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

NCT05957666 | Unknown Phase 2 DMC

• 1 other identifier: IRB/2023/1129/SIMS
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labour With Misoprostol

Keywords

induction of labour; misoprostol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• cesaerean section

  within 24 hours

• induction to delivery interval

  within 24 hours

• fetal distress

  within 24 hours

• uterine hyperstimulation

  more than 10 cotractions in every 10 minutes

Study Arms (2)

oral misoprostol

EXPERIMENTAL

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

vaginal misoprostol

ACTIVE COMPARATOR

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

Interventions

Misoprostol Oral Tablet DRUG

oral misoprostol 50 microgram repeated after 6 hours if required

Also known as: cytotec

oral misoprostol

vaginal misoprostol DRUG

vaginal misoprostol 50 microgram repeated after 6 hours if required

Also known as: cytotec

vaginal misoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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) -

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute Of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Tayyiba Wasim, FCPS

CONTACT

03008400197; tayyibawasim@yahoo.com

Kalsoom Waheed, FCPS

CONTACT

03214262687; zainabmohsin09@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obstetrics and Gynaecology

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: July 24, 2023
• Study Start: June 16, 2023
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

PA (1)