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To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour

NCT04887493 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-05-17

No results posted yet for this study

Summary

This research is to compare the efficacy and the safety of sublingual misoprostol with vaginal misoprostol administration for the induction of labour for primigravida at 41 or more weeks of pregnancy. In routine practice, misoprostol 25µg is used by per vaginal route for the induction of labour in Bhutan. The misoprostol dose is given repeatedly every 4 hours to a maximum of 6 dosages. The per vaginal route is found to be very effective and safe for the induction of labour. But, patient compliance is poor and increasing the risk of neonatal sepsis since it has to be inserted into vagina every 4 hours. To overcome these problems with per vaginal route, this study is developed to explore the efficacy and safety of misoprostol use by sublingual routes for the induction of labour. Misoprostol can be used by sublingual, oral or per vaginal route as per the findings of the other studies.

If the finding of this study proves sublingual use of misoprostol is safe and efficient for the induction of labour, the current practice of using misoprostol by vaginal route will be changed to sublingual route in Bhutan.

Conditions

  • Induction of Labour

Interventions

DRUG

Misoprostol

Misoprostol 25µg will be used for both the study arms

Sponsors & Collaborators

  • Ministry of Health, Bhutan

    lead OTHER_GOV

Principal Investigators

  • Yeshey Dorjey · Ministry of Health, Phuentsholing Hospital, Chukha, Bhutan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Bhutan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887493 on ClinicalTrials.gov