Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel... | NCT00355303

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

NCT00355303

Sponsor

Nilratan Sircar Medical College

Status

Completed

Last Update Posted

Jul 22, 2015Estimated

Enrollment

932Actual

Phase

Phase 4

Conditions

Premature Rupture of Membranes at Term

Interventions

Misoprostol
PGE2 gel

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 20, 2006

First Posted Date

Jul 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Snehamay Chaudhuri, Associate Professor , Obstetrics and Gynecology, NRS Medical College, Nilratan Sircar Medical CollegePrincipal Investigator

Lead Sponsor

Nilratan Sircar Medical CollegeOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

932Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol tablet, PGE2 gel	Active Comparator	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.	Drug: Misoprostol Drug: PGE2 gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses	Misoprostol tablet, PGE2 gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caesarean Section rate		48 hours

Secondary Outcomes

Measure	Description	Time Frame
Induction delivery time		48 hours
Neonatal & maternal infectious morbidity		14 days following date of delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Snehamay Chaudhuri, MBBS,MD.DNB	Nilratan Sircar Medical College , Kolkata, West bengal , India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nilratan Sircar Medical College, 138,AJC Bose Road,		Kolkata	West Bengal	700014	India

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol
D015232	Dinoprostone

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided