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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
Sponsor:
Collaborators:
Lund University Hospital
Skane University Hospital
Information provided by (Responsible Party):
Knut Haadem, Helsingborgs Hospital

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.


Condition or disease Intervention/treatment Phase
Perineal Tear Device: Perineal protection device Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Perineal Protection Device
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vaginal delivery

Exclusion Criteria:

  • Age below 18 years and no understanding of written and oral information.

Information from the National Library of Medicine

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


Locations
Sweden
Knut Haadem
Helsingborg, Sweden, 25187
Sponsors and Collaborators
Helsingborgs Hospital
Lund University Hospital
Skane University Hospital
Investigators
Principal Investigator: Knut Haadem, MD, PhD Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Knut Haadem, Principal investigator, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01533467     History of Changes
Other Study ID Numbers: KH-HBG-12
148/2008 ( Other Grant/Funding Number: Thelma Zoegas and Stig och Ragna Gortons Foundation )
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Knut Haadem, Helsingborgs Hospital:
Delivery rupture
perineal protection device
reduce perineal tears