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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033264
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE December 24, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Mode of delivery [ Time Frame: Up to 5 days. ]
Vaginal delivery in oppose to cesarean section.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Time to delivery [ Time Frame: Up to 5 days. ]
    Time from insertion of induction device\drug until delivery.
  • Induction success. [ Time Frame: Up to 5 days. ]
    Cervical dilatation and effacement after cessation of induction.
  • Neonatal complications and outcome. [ Time Frame: Up to 5 days. ]
    Any neonatal complications as mentioned In the neonate's electronic file.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.
Official Title  ICMJE A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Induction of Labor
Intervention  ICMJE
  • Drug: Dinoprostone
    10 mg of a Dinoprostone vaginal insert.
    Other Name: Prostaglandin E2
  • Device: Double lumen cervical ripening balloon.
    Double lumen cervical ripening balloon.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dinoprostone
  • 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.
    Intervention: Drug: Dinoprostone
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Double lumen cervical ripening balloon.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2020)
164
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
100
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033264
Other Study ID Numbers  ICMJE 0192-19-RMB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ROY LAUTERBACH MD, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ROY LAUTERBACH, MD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP