Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Study Overview
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Brief Summary
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The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Detailed Description
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The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Official Title
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Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant or surrogate is capable of giving informed consent Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy Participant is undergoing an indicated induction of labor Participant is found to have cervical Bishop score ≤5 on initial cervical exam Participant has no medical or obstetrical contraindications to induction of labor Exclusion Criteria: Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods Manufacturer's contraindications to misoprostol or oxytocin

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: Oxytocin<br>Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. | Drug: Oxytocin<br>* Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.<br>* Other names: pitocin;|
| Experimental: Misoprostol<br>Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement | Drug: Misoprostol<br>* Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Induction To Delivery | To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Route | To assess for differences in delivery routes | 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Ripening, Rate of Cesearean Section