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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04597333
Other study ID # 0009-20-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date December 31, 2021

Study information

Verified date April 2022
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 31, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
Dinoprostone
Dinoprostone vaginal insert.
Device:
Cervical ripening balloon.
Double lumen cervical ripening balloon.

Locations

Country Name City State
Israel Rambam health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delivery within 24 hours. Rate of delivery in 24 hours. From the time of induction up to 24 hours from induction.
Primary Time to delivery. The number of hours it takes to deliver. From the time of induction up to 120 hours from induction.
Secondary Mode of delivery. Vaginal and cesarean delivery rates. From the time of induction up to 120 hours from induction.
Secondary Uterine revision. The rate of uterine revision postpartum. From the time of induction up to 120 hours from induction.
Secondary Postpartum hemorrhage. The rate of postpartum hemorrhage. From the time of induction up to 120 hours from induction.
Secondary Chorioamnionitis. The rate of chorioamnionitis. From the time of induction up to 120 hours from induction.
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