A Randomized, Control Trial for Preinduction Cervical Rip... | NCT00393731

Studies
A Randomized, Control Trial for Preinduction Cervical Ripening

NCT00393731

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Jan 16, 2008Estimated

Enrollment

540Estimated

Phase

Phase 2

Conditions

Labor, Induced

Interventions

Misoprostol
oxytocin

Countries

United States

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

Jan 2008

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

Jan 2004

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Oct 26, 2006

First Submission Date that Met QC Criteria

Oct 26, 2006

First Posted Date

Oct 30, 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

Jan 11, 2008

Last Update Posted Date

Jan 16, 2008Estimated

Description Module

Brief Summary

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

540Estimated

Measure	Description	Time Frame
Vaginal Delivery rates

Measure	Description	Time Frame
Time interval to delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women that are hospitalized for induction of labor that have a Bishop's score <5
singleton gestation
cephalic presentation
24 weeks gestational age

Exclusion Criteria:

Prior uterine surgery
malpresentation
placenta previa or abruption
clinically suspected or diagnosed intra amniotic infection
genital HSV infection
multiple gestation
premature rupture of the membranes
active labor
maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Accepts Healthy Volunteers

Not provided

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
Michael Lucas, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lyndon B. Johnson Hospital		Houston	Texas	77026	United States

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol
D010121	Oxytocin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug
oxytocin	Drug