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Breast Stimulation Versus Pitocin for Induction of Labor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984347
First Posted: September 25, 2009
Last Update Posted: September 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.

Condition Intervention
Labor Induction Drug: Oxytocin Procedure: breast pump nipple stimulation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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

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

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
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
Israel
Hadassah University Hospital Mt. Scopus Not yet recruiting
Jerusalem, Israel
Principal Investigator: Yael Sciaky-Tamir, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Chair: Drorith Hochner-Celnikeir, MD Hadasah Medical Organization
  More Information

Responsible Party: Dr. Sciaky-Tamir Yael, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00984347     History of Changes
Other Study ID Numbers: 280808-HMO-CTIL
First Submitted: September 23, 2009
First Posted: September 25, 2009
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:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs