Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT01533467
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Device Designed to Protect the Perineum During Labor
Sponsor:
Helsingborgs Hospital
Organization:
Study Overview
Official Title:
Study of Perineal Protection Device
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 148/2008 | OTHER_GRANT | Thelma Zoegas and Stig och Ragna Gortons Foundation | View |