Breast Stimulation Versus Pitocin for Induction of Labor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00984347
First received: September 23, 2009
Last updated: September 24, 2009
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fetal distress (monitor assessment, cord ph) [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • cesarean section rate [ Time Frame: 24h ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: 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

No publications provided

Responsible Party: Dr. Sciaky-Tamir Yael, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00984347     History of Changes
Other Study ID Numbers: 280808-HMO-CTIL
Study First Received: September 23, 2009
Last Updated: September 24, 2009
Health Authority: Israel: Ministry of Health

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014