Labor InductionNCT00984347
Breast Stimulation Versus Pitocin for Induction of Labor
A study testing Oxytocin and breast pump nipple stimulation in people with Labor Induction, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- Oxytocin and breast pump nipple stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years and older
- completed 37 weeks gestation
- singleton pregnancy
- reassuring fetal heart rate at admission monitor
Who cannot join
- multiple pregnancies
- known fetal malformations
- non reassuring NST
- polyhydramnios (AFI>220)
- oligohydramnios
- PET
Show all 10Show fewer
- IUGR
- macrosomia (EFW >4000g)
- antepartum bleeding
- maternal fever
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Hospital Mt. Scopus
Jerusalem
Yael Sciaky-Tamir, MD
About this study
Official title: Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction
The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.
- Conditions
- Labor Induction
- Being tested
- Oxytocin, breast pump nipple stimulation
- Keywords
- nipple stimulation, Oxytocin, induction of labor, term pregnancies, grandmultipara, VBAC, PROM, comparison of two methods for induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin for injection 10u/ml Rotex Medica
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
breast pump nipple stimulationProcedure or surgery
breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin induction | Active comparator | women in need for induction of labor due to medical indications, will receive continuous IV oxytocin Receives: Drug: Oxytocin |
| Breast Stimultion | Active comparator | 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. Receives: Procedure: breast pump nipple stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from induction to delivery
Measured: 24h
Secondary outcomes (2)
fetal distress (monitor assessment, cord ph)
Measured: 24 h
cesarean section rate
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Drorith Hochner-Celnikeir, MD, Study chair, Hadasah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984347
- Sponsor's protocol ID
- 280808-HMO-CTIL
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction
- ClinicalTrials.gov ID
- NCT00984347
- Acronym / sponsor ID
- 280808-HMO-CTIL
- Conditions
- Labor Induction
- Keywords
- nipple stimulation, Oxytocin, induction of labor, term pregnancies, grandmultipara, VBAC, PROM, comparison of two methods for induction of labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin induction | Active comparator | Drug: Oxytocinwomen in need for induction of labor due to medical indications, will receive continuous IV oxytocin |
| Breast Stimultion | Active comparator | Procedure: breast pump nipple stimulationnipple 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years and older
- completed 37 weeks gestation
- singleton pregnancy
- reassuring fetal heart rate at admission monitor
Key exclusion criteria (10 listed)
- multiple pregnancies
- known fetal malformations
- non reassuring NST
- polyhydramnios (AFI>220)
- oligohydramnios
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Oxytocin for injection 10u/ml Rotex MedicaFor 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 | Drug | Oxytocin induction |
| breast pump nipple stimulationbreast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest | Procedure or surgery | Breast Stimultion |
Primary outcome
time from induction to delivery
Time frame: 24h
2 secondary outcomes
fetal distress (monitor assessment, cord ph)
Time frame: 24 h
cesarean section rate
Time frame: 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
Related trials for Labor Induction
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Active, not recruiting
Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin
Labor Induction, Cesarean Delivery
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruiting
COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix
Labor Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drorith Hochner-Celnikeir, MD study chair
Hadasah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and breast pump nipple stimulation in people with Labor Induction, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Sciaky-Tamir, MD (+972-2-5844111, yaels@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from induction to delivery (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009; AzTrials last refreshed its copy on 6 Nov 2026.