Breast Stimulation Versus Pitocin for Induction of Labor

Labor Induction Clinical Trial

Official title:

Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00984347
• Other study ID #: 280808-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2009
• Last updated: September 24, 2009
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: Hadassah Medical Organization
• Contact: Yael Sciaky-Tamir, MD
• Phone: +972-2-5844111
• Email: yaels[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Induction

Intervention

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

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

Locations

Country	Name	City	State
Israel	Hadassah University Hospital Mt. Scopus	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time from induction to delivery		24h	No
Secondary	fetal distress (monitor assessment, cord ph)		24 h	No
Secondary	cesarean section rate		24h	No