NCT04597333

Labor Induction After Failed Induction With Dinoprostone.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DRUG	Dinoprostone	Dinoprostone vaginal insert.
DEVICE	Cervical ripening balloon.	Double lumen cervical ripening balloon.

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-11-30
• Completion: 2021-12-31
• First posted: 2020-10-22
• Last updated: 2022-04-20

Locations

1 site across 1 country: Israel