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Breast Stimulation Versus Pitocin for Induction of Labor

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ClinicalTrials.gov Identifier: NCT00984347
Recruitment Status : Unknown
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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Brief Summary:
The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.

Condition or disease Intervention/treatment Phase
Labor Induction Drug: Oxytocin Procedure: breast pump nipple stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction
Study Start Date : November 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oxytocin induction
women in need for induction of labor due to medical indications, will receive continuous IV oxytocin
 Drug: Oxytocin

For low risk group (women at deliveries 1-5):

IV oxytocin 10IU/1000ml standard sol. starting at 2MU/MIN and augmenting 2MU every 20 min.

For high risk group (grandmultiparas [6th delivery and up] or women with a previous cesarean section)

IV oxytocin 5IU/1000ml standard sol. starting at 1MU/MIN augmenting 1MU every 20 MIN - in accordance with the department's protocol

Other Name: Oxytocin for injection 10u/ml Rotex Medica
Active Comparator: Breast Stimultion
nipple stimulation with a breast pump, calibrated at the lowest suction strength,operated alternately: 15 min one breast, 15 min second breast, 15 min rest, till appearance of regular uterine contractions (3 contractions in 10 min). the manipulation will continue for 3 hours of regular contractions.
 Procedure: breast pump nipple stimulation
breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest


Outcome Measures
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Primary Outcome Measures :
  1. time from induction to delivery [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. fetal distress (monitor assessment, cord ph) [ Time Frame: 24 h ]
  2. cesarean section rate [ Time Frame: 24h ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and older
  • completed 37 weeks gestation
  • singleton pregnancy
  • reassuring fetal heart rate at admission monitor

Exclusion Criteria:

  • multiple pregnancies
  • known fetal malformations
  • non reassuring NST
  • polyhydramnios (AFI>220)
  • oligohydramnios
  • PET
  • IUGR
  • macrosomia (EFW >4000g)
  • antepartum bleeding
  • maternal fever
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984347


Contacts
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Contact: Yael Sciaky-Tamir, MD +972-2-5844111 yaels@hadassah.org.il
Contact: Drorith Hochner-Celnikier, MD +972-2-8544410 Hochner@hadassah.org.il

Locations
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Israel
Hadassah University Hospital Mt. Scopus
Jerusalem, Israel
Principal Investigator: Yael Sciaky-Tamir, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Study Chair: Drorith Hochner-Celnikeir, MD Hadasah Medical Organization
More Information
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Responsible Party: Dr. Sciaky-Tamir Yael, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00984347    
Other Study ID Numbers: 280808-HMO-CTIL
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: September 2009
Keywords provided by Hadassah Medical Organization:
nipple stimulation
Oxytocin
induction of labor
term pregnancies
 grandmultipara
VBAC
PROM
comparison of two methods for induction of labor
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs