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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|