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

R

Rambam Health Care Campus

Status

Completed

Conditions

Induction of Labor

Treatments

Device: Double lumen cervical ripening balloon.
Drug: Dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT03033264
0192-19-RMB

Details and patient eligibility

About

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.

Full 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:

Dinoprostone in women with a BMI>30. Dinoprostone in women with a BMI<30. Cervical ripening balloon in women with a BMI>30. 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.

Enrollment

164 patients

Sex

Female

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 4 patient groups

BMI>30+Dinoprostone
Experimental group
Description:
Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
Treatment:
Drug: Dinoprostone
BMI<30+Dinoprostone
Experimental group
Description:
Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
Treatment:
Drug: Dinoprostone
BMI>30+Cervical ripening balloon
Experimental group
Description:
Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
Treatment:
Device: Double lumen cervical ripening balloon.
BMI<30+Cervical ripening balloon
Experimental group
Description:
Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
Treatment:
Device: Double lumen cervical ripening balloon.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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