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OpenTrials
Completed

NCT Number: NCT04597333

Labor Induction After Failed Induction With Dinoprostone.

Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women after induction of labor with Dinoprostone.
  • BISHOP score of under 5 after 1st induction attempt.
  • Nulliparous women.

Exclusion criteria

  • Women after induction of labor with a cervical ripening balloon.
  • BISHOP score of over 5 after 1st induction attempt.
  • Multiparous women.

Treatment and study plan

Dinoprostone

Drug

Dinoprostone vaginal insert.

Cervical ripening balloon.

Device

Double lumen cervical ripening balloon.

Primary outcomes

  1. Delivery within 24 hours.

    Time frame: From the time of induction up to 24 hours from induction.

    Rate of delivery in 24 hours.

  2. Time to delivery.

    Time frame: From the time of induction up to 120 hours from induction.

    The number of hours it takes to deliver.

Secondary outcomes

  1. Mode of delivery.

    Time frame: From the time of induction up to 120 hours from induction.

    Vaginal and cesarean delivery rates.

  2. Uterine revision.

    Time frame: From the time of induction up to 120 hours from induction.

    The rate of uterine revision postpartum.

  3. Postpartum hemorrhage.

    Time frame: From the time of induction up to 120 hours from induction.

    The rate of postpartum hemorrhage.

  4. Chorioamnionitis.

    Time frame: From the time of induction up to 120 hours from induction.

    The rate of chorioamnionitis.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Apr 20, 2022

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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