NCT01533467

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

February 6, 2012

Last Update Submit

February 12, 2012

Conditions

Perineal Tear

Keywords

Delivery ruptureperineal protection devicereduce perineal tears

Outcome Measures

Primary Outcomes (1)

  • Grade I and II rupture during delivery

    Number and extension of perineal tears during delivery

    time at the delivery department (up to 12 months)

Study Arms (2)

Perineal device used

OTHER

Use of the perineal device during delivery

Device: Perineal protection device

No intervention

NO INTERVENTION

Controls, delivered as normal

Interventions

Perineal protection deviceDEVICE

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

Also known as: Manufacturer; Calle Gejde AB, 234 21 Lomma, Sweden
Perineal device used

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Vaginal delivery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knut Haadem

Helsingborg, Helsingborg, 25187, Sweden

Location

Related Publications (1)

  • Lavesson T, Griph ID, Skarvad 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.

    PMID: 25126978DERIVED

Study Officials

  • Knut Haadem, MD, PhD

    Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 15, 2012

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

SE(1)