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

Rambam Health Care Campus

Status: Completed

Conditions: Induction of Labor

Treatments: Device: Double lumen cervical ripening balloon.; Drug: Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT03033264

0192-19-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 4 patient groups

BMI>30+Dinoprostone

Experimental group

Description:

Women with a BMI\>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Treatment:

Drug: Dinoprostone

BMI<30+Dinoprostone

Experimental group

Description:

Women with a BMI\<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Treatment:

Drug: Dinoprostone

BMI>30+Cervical ripening balloon

Experimental group

Description:

Women with a BMI\>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

Treatment:

Device: Double lumen cervical ripening balloon.

BMI<30+Cervical ripening balloon

Experimental group

Description:

Women with a BMI\<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

Treatment:

Device: Double lumen cervical ripening balloon.