Randomized Trial Comparing Misoprostol and Foley Bulb for... | NCT00325026

Studies
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

NCT00325026

Sponsor

University of Florida

Status

Completed

Last Update Posted

Mar 2, 2012Estimated

Enrollment

130Actual

Phase

Phase 2

Conditions

Premature Birth
Cervical Ripening

Interventions

Misoprostol
Foley bulb

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

May 10, 2006

First Submission Date that Met QC Criteria

May 10, 2006

First Posted Date

May 11, 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

Mar 1, 2012

Last Update Posted Date

Mar 2, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Detailed Description

Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

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

130Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to vaginal delivery

Secondary Outcomes

Measure	Description	Time Frame
Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton gestation, gestational age 23-35 weeks, indication for induction

Exclusion Criteria:

multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keri a Baacke, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shands Hospital at the University of Florida		Gainesville	Florida	32610	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36996264	Derived	de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

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

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug
Foley bulb	Device