Study of Different Suturing Techniques for Perineal Repair After Delivery

This study has been completed.
Sponsor:
Collaborators:
Danish Research Agency
Aase and Ejnar Danielsens Foundation
Aarhus University Hospital
The Danish Midwifery Organization
Sophus Jacobsen and wifes´ Foundation
Else and Mogens Wedell-Wedellsborgs´ Foundation
Frode V. Nyegaard and wifes´ Foundation
K.A. Rohde and wifes´ Foundation
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00265421
First received: December 13, 2005
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Perineal Lacerations
Episiotomy
Procedure: Suture technique for perineal repair after delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pain in perineal area day 1 and 10 after delivery.
  • Healing of wound day 1 and 10 after delivery.

Secondary Outcome Measures:
  • Patient satisfaction with perineal sutures performed at birth.
  • Incontinence.
  • Need for resuturing of perineal area within 1 year after delivery.

Estimated Enrollment: 400
Study Start Date: August 2004
Estimated Study Completion Date: April 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00265421

Locations
Denmark
Dept. of Obstetrics and Gynaecology, Skejby Sygehus
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Research Agency
Aase and Ejnar Danielsens Foundation
Aarhus University Hospital
The Danish Midwifery Organization
Sophus Jacobsen and wifes´ Foundation
Else and Mogens Wedell-Wedellsborgs´ Foundation
Frode V. Nyegaard and wifes´ Foundation
K.A. Rohde and wifes´ Foundation
Investigators
Study Chair: Niels Uldbjerg, Professor Aarhus University Hopspital, dept. of Obst. & Gyn.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265421     History of Changes
Other Study ID Numbers: The Danish Suture Trial, 2004-70 Etichs Committee
Study First Received: December 13, 2005
Last Updated: September 29, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Suture Techniques

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014