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To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dinoprostone Vaginal Insert | Active Comparator |
| |
| Double Balloon Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double balloon catheter | Device | The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal delivery within 24 hours | 24 hours from start of cervical ripening |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean section rate | 48 hours from start of ripening | |
| Onset of active labor | Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ā„3 cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Ponte Hospital | Varese | 21100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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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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|
| Dinoprostone 10 mg controlled-release vaginal insert | Drug | Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours. |
|
|
| 36 hours from start of ripening |
| Uterine hyperstimulation | 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |