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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

Tracking Information
First Submitted Date  ICMJE September 23, 2009
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date September 25, 2009
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
time from induction to delivery [ Time Frame: 24h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
  • fetal distress (monitor assessment, cord ph) [ Time Frame: 24 h ]
  • cesarean section rate [ Time Frame: 24h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breast Stimulation Versus Pitocin for Induction of Labor
Official Title  ICMJE Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Labor Induction
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Oxytocin induction
    women in need for induction of labor due to medical indications, will receive continuous IV oxytocin
    Intervention: Drug: Oxytocin
  • 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.
    Intervention: Procedure: breast pump nipple stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984347
Other Study ID Numbers  ICMJE 280808-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sciaky-Tamir Yael, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Drorith Hochner-Celnikeir, MD Hadasah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP