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Labor Induction After Failed Induction With Dinoprostone.

Not Applicable
Completed
Conditions
Induction of Labor Affected Fetus / Newborn
Interventions
Device: Cervical ripening balloon.
Drug: Dinoprostone
Registration Number
NCT04597333
Lead Sponsor
Rambam Health Care Campus
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
144
Inclusion Criteria
  • Women after induction of labor with Dinoprostone.
  • BISHOP score of under 5 after 1st induction attempt.
  • Nulliparous women.
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Exclusion Criteria
  • Women after induction of labor with a cervical ripening balloon.
  • BISHOP score of over 5 after 1st induction attempt.
  • Multiparous women.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cervical ripening balloon.Cervical ripening balloon.Women induced with a cervical ripening balloon.
2nd Dinoprostone.DinoprostoneWomen induced with a second dinoprostone insert.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Rambam health care campus

🇮🇱

Haifa, Israel

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