A Device Designed to Protect the Perineum During Labor

February 12, 2012 updated by: Knut Haadem, Helsingborgs Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden, 25187
        • Knut Haadem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Vaginal delivery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
No Intervention: No intervention
Controls, delivered as normal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
time at the delivery department (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsingborgs Hospital

Collaborators

Skane University Hospital
Lund University Hospital

Investigators

  • Principal Investigator: Knut Haadem, MD, PhD, Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 12, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 12, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KH-HBG-12
  • 148/2008 (Other Grant/Funding Number: Thelma Zoegas and Stig och Ragna Gortons Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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