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OpenTrials
Completed

NCT Number: NCT01533467

A Device Designed to Protect the Perineum During Labor

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.

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Key information

Conditions

Perineal Tear

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Knut Haadem

Helsingborg, 25187, Sweden

About this study

Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Vaginal delivery

Exclusion criteria

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

Treatment and study plan

Perineal protection device

Device

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

Other names: Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsingborgs Hospital

Other

Collaborators

  • Lund University Hospital
  • Skane University Hospital

Registry information

Official study title

Study of Perineal Protection Device

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2012
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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