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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

NCT ID: NCT00684606

Last Updated: 2008-06-19

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Induction of Labor

Keywords

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Induction of Labor Low Bishop Score Transcervical Foley Catheter. IV Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Transcervical Foley catheter with IV Oxytocin

Group Type EXPERIMENTAL

Oxytocin IV

Intervention Type DRUG

5 miu/1000ml Glu/Saline

2

Transcervical Foley catheter only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxytocin IV

5 miu/1000ml Glu/Saline

Intervention Type DRUG

Other Intervention Names

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Pitocin

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Cener

Principal Investigators

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Orit Moran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba medical center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Orit Moran, MD

Role: CONTACT

Phone: 972-3-5302777

Email: [email protected]

Baruch Feldman, MD, PhD

Role: CONTACT

Phone: 972-3-5303934

Email: [email protected]

Facility Contacts

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Orit Moran, MD

Role: primary

Other Identifiers

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SHEBA-08-5164-OM-CTIL

Identifier Type: -

Identifier Source: org_study_id