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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

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
Induction of Labor Drug: Dinoprostone Device: Double lumen cervical ripening balloon. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Mode of delivery [ Time Frame: Up to 5 days. ]
    Vaginal delivery in oppose to cesarean section.


Secondary Outcome Measures :
  1. Time to delivery [ Time Frame: Up to 5 days. ]
    Time from insertion of induction device\drug until delivery.

  2. Induction success. [ Time Frame: Up to 5 days. ]
    Cervical dilatation and effacement after cessation of induction.

  3. Neonatal complications and outcome. [ Time Frame: Up to 5 days. ]
    Any neonatal complications as mentioned In the neonate's electronic file.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033264


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: ROY LAUTERBACH, MD Rambam Health Care Campus
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03033264    
Other Study ID Numbers: 0192-19-RMB
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs