Labor Induction After Failed Induction With Dinoprostone.

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597333
• Other study ID #: 0009-20-RMB
• Status: Completed
• Phase: N/A
• 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
• 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.

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.