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A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.
160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Balloon Catheter | Active Comparator | Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin |
|
| Double balloon catheter | Active Comparator | Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley Catheter | Device | Foley Catheter 16-19 H |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cervix dilatation >= 3cm | Cervix dilatation is assessed by vaginally examination at Catheter removal. | At cather removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womens Hospital, Haukeland University Hospital | Bergen | Norway |
| 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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| Double Balloon Catheter |
| Device |
Double Balloon Catheter for 16-19H |
|
|