NCT03033264

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

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: 1. Dinoprostone in women with a BMI\>30. 2. Dinoprostone in women with a BMI\<30. 3. Cervical ripening balloon in women with a BMI\>30. 4. 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

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: 1. Dinoprostone in women with a BMI\>30. 2. Dinoprostone in women with a BMI\<30. 3. Cervical ripening balloon in women with a BMI\>30. 4. 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.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
DRUG	Dinoprostone	10 mg of a Dinoprostone vaginal insert.
DEVICE	Double lumen cervical ripening balloon.	Double lumen cervical ripening balloon.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-07-31
• Completion: 2020-10-01
• First posted: 2017-01-26
• Last updated: 2020-10-19

Locations

1 site across 1 country: Israel