Labor Induction After Failed Induction With Dinoprostone.

Rambam Health Care Campus

Status: Completed

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Device: Cervical ripening balloon.; Drug: Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT04597333

0009-20-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

2nd Dinoprostone.

Active Comparator group

Description:

Women induced with a second dinoprostone insert.

Treatment:

Drug: Dinoprostone

Cervical ripening balloon.

Active Comparator group

Description:

Women induced with a cervical ripening balloon.

Treatment:

Device: Cervical ripening balloon.