Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.

Study Overview
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Brief Summary
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Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value: Dinoprostone in women with a BMI>30. Dinoprostone in women with a BMI<30. Cervical ripening balloon in women with a BMI>30. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

Detailed Description
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The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value: Dinoprostone in women with a BMI>30. Dinoprostone in women with a BMI<30. Cervical ripening balloon in women with a BMI>30. Cervical ripening balloon in women with a BMI<30. All subjects participating in the study will be induced for obstetrical indications alone. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files. The participants will finish participation in the study after delivery.

Official Title
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A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Dinoprostone
* Device: Double lumen cervical ripening balloon.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any pregnant woman at term with an obstetric indication for labor induction. Exclusion Criteria: Previous cesarean section. Positive Oxytocin challenge test. Positive contraction stress test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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 |
| --- | --- |
| Experimental: BMI>30+Dinoprostone<br>Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. | Drug: Dinoprostone<br>* 10 mg of a Dinoprostone vaginal insert.<br>* Other names: Prostaglandin E2;|
| Experimental: BMI<30+Dinoprostone<br>Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. | Drug: Dinoprostone<br>* 10 mg of a Dinoprostone vaginal insert.<br>* Other names: Prostaglandin E2;|
| Experimental: BMI>30+Cervical ripening balloon<br>Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. | Device: Double lumen cervical ripening balloon.<br>* Double lumen cervical ripening balloon.<br>|
| Experimental: BMI<30+Cervical ripening balloon<br>Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. | Device: Double lumen cervical ripening balloon.<br>* Double lumen cervical ripening balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Vaginal delivery in oppose to cesarean section. | Up to 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to delivery | Time from insertion of induction device\drug until delivery. | Up to 5 days. | 
| Induction success. | Cervical dilatation and effacement after cessation of induction. | Up to 5 days. | 
| Neonatal complications and outcome. | Any neonatal complications as mentioned In the neonate's electronic file. | Up to 5 days. |