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| ID | Type | Description | Link |
|---|---|---|---|
| 148/2008 | Other Grant/Funding Number | Thelma Zoegas and Stig och Ragna Gortons Foundation |
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| Name | Class |
|---|---|
| Lund University Hospital | OTHER |
| Skane University Hospital | OTHER |
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Objective:
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
Design:
A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.
Main outcome measures:
The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal device used | Other | Use of the perineal device during delivery |
|
| No intervention | No Intervention | Controls, delivered as normal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal protection device | Device | Use of the device during delivery and inspection afterwards to see the tears. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade I and II rupture during delivery | Number and extension of perineal tears during delivery | time at the delivery department (up to 12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Haadem, MD, PhD | Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knut Haadem | Helsingborg | Helsingborg | 25187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25126978 | Derived | Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30. |
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