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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04597333

Enrollment

144

Registered

2020-10-22

Start date

2020-10-15

Completion date

2021-12-31

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

Brief 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.

Interventions

DRUGDinoprostone

Dinoprostone vaginal insert.

DEVICECervical ripening balloon.

Double lumen cervical ripening balloon.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Delivery within 24 hours.	From the time of induction up to 24 hours from induction.	Rate of delivery in 24 hours.
Time to delivery.	From the time of induction up to 120 hours from induction.	The number of hours it takes to deliver.

Secondary

Measure	Time frame	Description
Mode of delivery.	From the time of induction up to 120 hours from induction.	Vaginal and cesarean delivery rates.
Uterine revision.	From the time of induction up to 120 hours from induction.	The rate of uterine revision postpartum.
Postpartum hemorrhage.	From the time of induction up to 120 hours from induction.	The rate of postpartum hemorrhage.
Chorioamnionitis.	From the time of induction up to 120 hours from induction.	The rate of chorioamnionitis.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026