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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

February 6, 2012
February 15, 2012
February 15, 2012
November 2010
November 2011   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Device Designed to Protect the Perineum During Labor
Study of Perineal Protection Device

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Perineal Tear
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
  • Perineal device used
    Use of the perineal device during delivery
    Intervention: Device: Perineal protection device
  • No Intervention: No intervention
    Controls, delivered as normal
Lavesson T, Griph ID, Skärvad 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
Same as current
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Vaginal delivery

Exclusion Criteria:

  • Age below 18 years and no understanding of written and oral information.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01533467
KH-HBG-12
148/2008 ( Other Grant/Funding Number: Thelma Zoegas and Stig och Ragna Gortons Foundation )
No
Not Provided
Not Provided
Knut Haadem, Helsingborgs Hospital
Helsingborgs Hospital
  • Lund University Hospital
  • Skane University Hospital
Principal Investigator: Knut Haadem, MD, PhD Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden
Helsingborgs Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP