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
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Condition or disease | Intervention/treatment | Phase |
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Labor Induction | Drug: Oxytocin Procedure: breast pump nipple stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
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 |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | October 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Oxytocin induction
women in need for induction of labor due to medical indications, will receive continuous IV oxytocin
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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.
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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 |
- time from induction to delivery [ Time Frame: 24h ]
- fetal distress (monitor assessment, cord ph) [ Time Frame: 24 h ]
- cesarean section rate [ Time Frame: 24h ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Yael Sciaky-Tamir, MD | +972-2-5844111 | yaels@hadassah.org.il | |
Contact: Drorith Hochner-Celnikier, MD | +972-2-8544410 | Hochner@hadassah.org.il |
Israel | |
Hadassah University Hospital Mt. Scopus | |
Jerusalem, Israel | |
Principal Investigator: Yael Sciaky-Tamir, MD |
Study Chair: | Drorith Hochner-Celnikeir, MD | Hadasah Medical Organization |
Responsible Party: | Dr. Sciaky-Tamir Yael, Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00984347 |
Other Study ID Numbers: |
280808-HMO-CTIL |
First Posted: | September 25, 2009 Key Record Dates |
Last Update Posted: | September 25, 2009 |
Last Verified: | September 2009 |
nipple stimulation Oxytocin induction of labor term pregnancies |
grandmultipara VBAC PROM comparison of two methods for induction of labor |
Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |