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

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033264
• Other study ID #: 0192-19-RMB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Dinoprostone
10 mg of a Dinoprostone vaginal insert.

Device:
• Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of delivery	Vaginal delivery in oppose to cesarean section.	Up to 5 days.
Secondary	Time to delivery	Time from insertion of induction device\drug until delivery.	Up to 5 days.
Secondary	Induction success.	Cervical dilatation and effacement after cessation of induction.	Up to 5 days.
Secondary	Neonatal complications and outcome.	Any neonatal complications as mentioned In the neonate's electronic file.	Up to 5 days.