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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2nd Dinoprostone. | Active Comparator | Women induced with a second dinoprostone insert. |
|
| Cervical ripening balloon. | Active Comparator | Women induced with a cervical ripening balloon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone | Drug | Dinoprostone vaginal insert. |
| |
| Cervical ripening balloon. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female.
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| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Device |
Double lumen cervical ripening balloon. |
|
| 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. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |