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OpenTrials
Completed

NCT Number: NCT03033264

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

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.

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Key information

Conditions

Induction of Labor

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dinoprostone

Drug

10 mg of a Dinoprostone vaginal insert.

Other names: Prostaglandin E2

Double lumen cervical ripening balloon.

Device

Double lumen cervical ripening balloon.

Primary outcomes

  1. Mode of delivery

    Time frame: Up to 5 days.

    Vaginal delivery in oppose to cesarean section.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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