Breast Stimulation Versus Pitocin for Induction of Labor

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

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

Conditions
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Labor Induction

Intervention / Treatment
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* Drug: Oxytocin
* Procedure: breast pump nipple stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin induction<br>women in need for induction of labor due to medical indications, will receive continuous IV oxytocin | Drug: Oxytocin<br>* 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<br>* Other names: Oxytocin for injection 10u/ml Rotex Medica;|
| Active Comparator: Breast Stimultion<br>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<br>* breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from induction to delivery |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal distress (monitor assessment, cord ph) |  | 24 h | 
| cesarean section rate |  | 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nipple stimulation, Oxytocin, induction of labor, term pregnancies, grandmultipara, VBAC, PROM, comparison of two methods for induction of labor