Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

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.

Study Overview

• Status: Recruiting
• Conditions: Induction of Labour With Misoprostol
• Intervention / Treatment: Drug: Misoprostol Oral Tablet; Drug: vaginal misoprostol

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.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Tayyiba Wasim, FCPS; Phone Number: 92 03008400197; Email: tayyibawasim@yahoo.com
• Study Contact Backup: Name: Kalsoom Waheed, FCPS; Phone Number: 92 03214262687; Email: zainabmohsin09@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Services Institute of Medical Sciences
      • Contact: Tayyiba Wasim, FCPS; Phone Number: 92 03008400197; Email: tayyibawasim@yahoo.com
      • Contact: Kalsoom Waheed, FCPS; Phone Number: 92 03214262687; Email: zainabmohsin09@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Misoprostol Oral Tablet; oral misoprostol 50 microgram repeated after 6 hours if required; Other Names: cytotec
Active Comparator: 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	Drug: vaginal misoprostol; vaginal misoprostol 50 microgram repeated after 6 hours if required; Other Names: cytotec

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Estimated): December 16, 2023
• Study Completion (Estimated): December 16, 2023

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: induction of labour; misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: IRB/2023/1129/SIMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No