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Induction of Labor by Oral Misoprostol Solution

NCT04891679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2021-05-18

No results posted yet for this study

Summary

AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with static-dose oral misoprostol solution for induction of labor at term.

Women with singleton live pregnancy at term without any complications who were admitted in labor room for induction of labor were enrolled.

Study involves allocation of selected women in two groups randomly and use of either titrated or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid induction of labor with oral drug regimen which is easier to comply as compared to vaginal regimens. Women were at risk of all the complications associated with induction of labor like labor abnormalities, risk of cesarean section, non reassuring fetal status.

Conditions

  • Induction of Labor

Interventions

DRUG

Oral misoprostol solution (OMS)

Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours. Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below. 0 hour= 20ml 1. hour= 20ml 2. hour= 30ml 3. hour= 30ml 4. hour= 30ml 5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

Sponsors & Collaborators

  • Christian Medical College and Hospital, Ludhiana, India

    lead OTHER

Principal Investigators

  • SUNITA GOYAL, MBBS, MD · Department of obstetrics and gynecology, Christian Medical College and hospital, Ludhiana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • India

Study Locations

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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 NCT04891679 on ClinicalTrials.gov