A Device Designed to Protect the Perineum During Labor

This study has been completed.
Sponsor:
Collaborators:
Lund University Hospital
Skane University Hospital
Information provided by (Responsible Party):
Knut Haadem, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01533467
First received: February 6, 2012
Last updated: February 12, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Perineal Tear
Device: Perineal protection device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Perineal Protection Device

Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:
  • Grade I and II rupture during delivery [ Time Frame: time at the delivery department (up to 12 months) ] [ Designated as safety issue: Yes ]
    Number and extension of perineal tears during delivery


Enrollment: 1200
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Knut Haadem, Principal investigator, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01533467     History of Changes
Other Study ID Numbers: KH-HBG-12, 148/2008
Study First Received: February 6, 2012
Last Updated: February 12, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on April 17, 2014