Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.
NCT ID: NCT03033264
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2017-01-01
2020-10-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Dinoprostone
10 mg of a Dinoprostone vaginal insert.
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.
Dinoprostone
10 mg of a Dinoprostone vaginal insert.
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.
Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.
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.
Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.
Interventions
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Dinoprostone
10 mg of a Dinoprostone vaginal insert.
Double lumen cervical ripening balloon.
Double lumen cervical ripening balloon.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive Oxytocin challenge test.
* Positive contraction stress test.
18 Years
44 Years
FEMALE
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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ROY LAUTERBACH MD
Principal Investigator
Principal Investigators
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ROY LAUTERBACH, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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0192-19-RMB
Identifier Type: -
Identifier Source: org_study_id
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