A Device Designed to Protect the Perineum During Labor
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|ClinicalTrials.gov Identifier: NCT01533467|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
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.
|Condition or disease||Intervention/treatment||Phase|
|Perineal Tear||Device: Perineal protection device||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Perineal Protection Device|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Perineal device used
Use of the perineal device during delivery
Device: Perineal protection device
Use of the device during delivery and inspection afterwards to see the tears.
Other Name: Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
No Intervention: No intervention
Controls, delivered as normal
- Grade I and II rupture during delivery [ Time Frame: time at the delivery department (up to 12 months) ]Number and extension of perineal tears during delivery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533467
|Helsingborg, Sweden, 25187|
|Principal Investigator:||Knut Haadem, MD, PhD||Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden|