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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033264

Enrollment

164

Registered

2017-01-26

Start date

2017-01-01

Completion date

2020-10-01

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor

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.

Interventions

DRUGDinoprostone

10 mg of a Dinoprostone vaginal insert.

DEVICEDouble lumen cervical ripening balloon.

Double lumen cervical ripening balloon.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Mode of delivery	Up to 5 days.	Vaginal delivery in oppose to cesarean section.

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026