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A Device Designed to Protect the Perineum During Labor

NCT01533467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2012-02-15

No results posted yet for this study

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.

Conditions

  • Perineal Tear

Interventions

DEVICE

Perineal protection device

Use of the device during delivery and inspection afterwards to see the tears.

Sponsors & Collaborators

  • Lund University Hospital

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • Helsingborgs Hospital

    lead OTHER

Principal Investigators

  • Knut Haadem, MD, PhD · Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533467 on ClinicalTrials.gov