Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

NCT ID: NCT00355303

Last Updated: 2015-07-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

932 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Rupture of Membranes at Term

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Misoprostol tablet, PGE2 gel

participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses

PGE2 gel

Intervention Type DRUG

PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol

Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses

Intervention Type DRUG

PGE2 gel

PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Misoprost Dinoprostone gel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Premature rupture of membranes at 37 or more weeks
* Single live fetus in cephalic presentation

Exclusion Criteria

* Women in labour
* Women with contraindication of induction of labour
* Women with previous caesarean section or uterine surgery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nilratan Sircar Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Snehamay Chaudhuri

Associate Professor , Obstetrics and Gynecology, NRS Medical College

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Snehamay Chaudhuri, MBBS,MD.DNB

Role: PRINCIPAL_INVESTIGATOR

Nilratan Sircar Medical College , Kolkata, West bengal , India

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nilratan Sircar Medical College, 138,AJC Bose Road,

Kolkata, West Bengal, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Related Links

Access external resources that provide additional context or updates about the study.

http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1447-0756

Chaudhuri, S et al. (2011), Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: A randomized comparative trial.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2-Chaudhuri

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.