Labor Induction After Failed Induction With Dinoprostone.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Dinoprostone
* Device: Cervical ripening balloon.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2nd Dinoprostone.<br>Women induced with a second dinoprostone insert. | Drug: Dinoprostone<br>* Dinoprostone vaginal insert.<br>|
| Active Comparator: Cervical ripening balloon.<br>Women induced with a cervical ripening balloon. | Device: Cervical ripening balloon.<br>* Double lumen cervical ripening balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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