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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

December 13, 2005
September 29, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Female
15 Years to 45 Years
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
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