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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT03033264
Collaborator
(none)
164
Enrollment
1
Location
4
Arms
45
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMI>30+Dinoprostone

Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Drug: Dinoprostone
10 mg of a Dinoprostone vaginal insert.
Other Names:
  • Prostaglandin E2

    		•
    Experimental: BMI<30+Dinoprostone

    Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

    Drug: Dinoprostone
    10 mg of a Dinoprostone vaginal insert.
    Other Names:
  • Prostaglandin E2

    		•
    Experimental: BMI>30+Cervical ripening balloon

    Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

    Device: Double lumen cervical ripening balloon.
    Double lumen cervical ripening balloon.
    Experimental: BMI<30+Cervical ripening balloon

    Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

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

    Outcome Measures

    Primary Outcome Measures

    1. Mode of delivery [Up to 5 days.]

      Vaginal delivery in oppose to cesarean section.

    Secondary Outcome Measures

    1. Time to delivery [Up to 5 days.]

      Time from insertion of induction device\drug until delivery.

    2. Induction success. [Up to 5 days.]

      Cervical dilatation and effacement after cessation of induction.

    3. Neonatal complications and outcome. [Up to 5 days.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam health care campus Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    • Principal Investigator: ROY LAUTERBACH, MD, Rambam Health Care Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT03033264
    Other Study ID Numbers:
    • 0192-19-RMB
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dinoprostone

    Study Results

    No Results Posted as of Oct 19, 2020