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

History of Changes

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:

Drug Information available for: Oxytocin

U.S. FDA Resources

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

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 (Adult)
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


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

ClinicalTrials.gov processed this record on September 30, 2016

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