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

NCT03033264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Induction of Labor

Interventions

DRUG

Dinoprostone

10 mg of a Dinoprostone vaginal insert.

DEVICE

Double lumen cervical ripening balloon.

Double lumen cervical ripening balloon.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • ROY LAUTERBACH, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-07-31
Completion
2020-10-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033264 on ClinicalTrials.gov