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Study of Different Suturing Techniques for Perineal Repair After Delivery

NCT ID: NCT00265421

Last Updated: 2009-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-04-30

Brief Summary

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We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.

The participants are healthy primi para and deliver at term.

Detailed Description

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A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas \>36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy.

The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.

Conditions

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Perineal Lacerations Episiotomy

Keywords

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Suture Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Suture technique for perineal repair after delivery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.

Exclusion Criteria

Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Research Agency

OTHER

Sponsor Role collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

The Danish Midwifery Organization

UNKNOWN

Sponsor Role collaborator

Sophus Jacobsen and wifes´ Foundation

UNKNOWN

Sponsor Role collaborator

Else and Mogens Wedell-Wedellsborgs´ Foundation

UNKNOWN

Sponsor Role collaborator

Frode V. Nyegaard and wifes´ Foundation

UNKNOWN

Sponsor Role collaborator

K. A. Rohde's and wife's Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Niels Uldbjerg, Professor

Role: STUDY_CHAIR

Aarhus University Hopspital, dept. of Obst. & Gyn.

Locations

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Dept. of Obstetrics and Gynaecology, Skejby Sygehus

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2004-70 Etichs Committee

Identifier Type: -

Identifier Source: secondary_id

The Danish Suture Trial

Identifier Type: -

Identifier Source: org_study_id