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

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Drug: Dinoprostone; Device: Double lumen cervical ripening balloon.

• Registration Number: NCT03033264
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-24
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2020-07-31
• Status Verified: 2020-10
• Study Completion: 2020-10-01
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI>30+Dinoprostone	Dinoprostone	Women with a BMI\>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
BMI>30+Cervical ripening balloon	Double lumen cervical ripening balloon.	Women with a BMI\>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
BMI<30+Cervical ripening balloon	Double lumen cervical ripening balloon.	Women with a BMI\<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
BMI<30+Dinoprostone	Dinoprostone	Women with a BMI\<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Primary Outcome Measures

Name	Time	Method
Mode of delivery	Up to 5 days.	Vaginal delivery in oppose to cesarean section.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel