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Study of Different Suturing Techniques for Perineal Repair After Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265421
First Posted: December 14, 2005
Last Update Posted: September 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
December 13, 2005
December 14, 2005
September 30, 2009
August 2004
Not Provided
  • Pain in perineal area day 1 and 10 after delivery.
  • Healing of wound day 1 and 10 after delivery.
Same as current
Complete list of historical versions of study NCT00265421 on ClinicalTrials.gov Archive Site
  • Patient satisfaction with perineal sutures performed at birth.
  • Incontinence.
  • Need for resuturing of perineal area within 1 year after delivery.
Same as current
Not Provided
Not Provided
 
Study of Different Suturing Techniques for Perineal Repair After Delivery
The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Perineal Lacerations
  • Episiotomy
Procedure: Suture technique for perineal repair after delivery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
April 2006
Not Provided

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.

Sexes Eligible for Study: Female
15 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00265421
The Danish Suture Trial
2004-70 Etichs Committee
Yes
Not Provided
Not Provided
Not Provided
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
Study Chair: Niels Uldbjerg, Professor Aarhus University Hopspital, dept. of Obst. & Gyn.
University of Aarhus
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP