Transcervical Foley Catheter With or Without Oxytocin for... | NCT00684606

Studies
Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

NCT00684606

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 19, 2008Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Pregnancy
Induction of Labor

Interventions

Oxytocin IV

Countries

Israel

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

May 22, 2008

First Submission Date that Met QC Criteria

May 23, 2008

First Posted Date

May 26, 2008Estimated

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

Jun 18, 2008

Last Update Posted Date

Jun 19, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Detailed Description

Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Transcervical Foley catheter with IV Oxytocin	Drug: Oxytocin IV
2	No Intervention	Transcervical Foley catheter only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin IV	Drug	5 miu/1000ml Glu/Saline	1	Pitocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.		year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term pregnancy
Medical indication for labor induction by transcervical Foley catheter

Exclusion Criteria:

Preterm pregnancy
Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:
- Uterine scar
- Multiple pregnancy
- PROM
- Grand-multiparity
- Placenta previa or marginal placenta
- Spontaneous uterine contractions (more than 3 in 10 minutes)
- Vaginal bleeding
- Nonreassuring fetal heart rate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orit Moran, MD	Contact	972-3-5302777		orit.moran@sheba.health.gov.il
Baruch Feldman, MD, PhD	Contact	972-3-5303934		baruch.feldman@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Orit Moran, M.D.	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba medical center	Recruiting	Ramat Gan			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided