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

Rambam Health Care Campus164 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Induction of Labor

Interventions

DinoprostoneDRUG

10 mg of a Dinoprostone vaginal insert.

Double lumen cervical ripening balloon.DEVICE

Double lumen cervical ripening balloon.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rambam health care campus

Haifa, Israel

Outcomes

Primary Outcomes

Mode of delivery

Vaginal delivery in oppose to cesarean section.

Time frame: Up to 5 days.

Secondary Outcomes

Time to delivery

Time from insertion of induction device\\drug until delivery.

Time frame: Up to 5 days.

Induction success.

Cervical dilatation and effacement after cessation of induction.

Time frame: Up to 5 days.

Neonatal complications and outcome.

Any neonatal complications as mentioned In the neonate's electronic file.

Time frame: Up to 5 days.

Data from ClinicalTrials.gov

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