Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Sheba Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00684606
First received: May 22, 2008
Last updated: June 18, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy Induction of Labor |
Drug: Oxytocin IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion. [ Time Frame: year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Transcervical Foley catheter with IV Oxytocin
|
Drug: Oxytocin IV
5 miu/1000ml Glu/Saline
Other Name: Pitocin
|
|
No Intervention: 2
Transcervical Foley catheter only
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684606
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684606
Contacts
| Contact: Orit Moran, MD | 972-3-5302777 | orit.moran@sheba.health.gov.il | |
| Contact: Baruch Feldman, MD, PhD | 972-3-5303934 | baruch.feldman@sheba.health.gov.il |
Locations
| Israel | |
| Sheba medical center | Recruiting |
| Ramat-Gan, Israel | |
| Contact: Orit Moran, MD 972-3-5302777 orit.moran@sheba.health.gov.il | |
| Principal Investigator: Orit Moran, MD | |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Orit Moran, M.D. | Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Orit Moran, Sheba Medical Cener |
| ClinicalTrials.gov Identifier: | NCT00684606 History of Changes |
| Other Study ID Numbers: | SHEBA-08-5164-OM-CTIL |
| Study First Received: | May 22, 2008 |
| Last Updated: | June 18, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
Induction of Labor Low Bishop Score Transcervical Foley Catheter. IV Oxytocin |
Additional relevant MeSH terms:
|
Oxytocin Oxytocics Pharmacologic Actions |
Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015