Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

Study Overview
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Brief Summary
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The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

Official Title
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A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: pitocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a singleton pregnancy Term pregnancy (> 37 weeks gestation) Age ≥ 18 years Bishop score < 5 Contractions < 6/hr Reassuring fetal heart tracing Exclusion Criteria: Rupture of membranes Antepartum bleeding Fetal death Placenta previa or low lying placenta Active genital herpes infection Previous use of an induction or preinduction agent during the current pregnancy EFW >4500 grams Non reassuring fetal testing Inability to pass foley through cervix Prior cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: foley bulb induction with low dose pitocin<br>Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. | Drug: pitocin<br> <br> * Other names: oxytocin;|
| Active Comparator: foley bulb with standard incremental pitocin infusion protocol<br>Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. | Drug: pitocin<br> <br> * Other names: oxytocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the Second Stage of Labor | The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus. | foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days) | 
| Time to Delivery | Time from foley balloon placement until neonate delivery | foley bulb placement until delivery (during admission for delivery, up to approximately 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cesarean Delivery | Number of participants having a cesarean delivery | during admission for delivery, up to approximately 4 days | 
| Time to Active Labor | Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women. | during admission for delivery, up to approximately 4 days | 
| Time to Foley Expulsion or Removal | Time from foley balloon placement until the expulsion or removal of the foley balloon. | foley bulb placement until removal, up to 10 hours | 
| Incidence of Uterine Hyperstimulation | Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes. | during admission for delivery, up to approximately 4 days | 
| Neonatal Outcome: Birthweight |  | at time of birth (0 to 1 hour) | 
| Neonatal Outcome: Placental Abruption | number of participants with placental abruption | during admission for delivery, up to approximately 4 days | 
| Neonatal Outcome: Late Fetal Heart Rate Decelerations | Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction. | during admission for delivery, up to approximately 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pitocin, induction of labor, foley bulb