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Study of Different Suturing Techniques for Perineal Repair After Delivery

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ClinicalTrials.gov Identifier: NCT00265421
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : September 30, 2009
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Perineal Lacerations Episiotomy Procedure: Suture technique for perineal repair after delivery

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
Study Start Date : August 2004
Estimated Study Completion Date : April 2006
Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265421

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
Study Chair: Niels Uldbjerg, Professor Aarhus University Hopspital, dept. of Obst. & Gyn.
More Information

ClinicalTrials.gov Identifier: NCT00265421     History of Changes
Other Study ID Numbers: The Danish Suture Trial
2004-70 Etichs Committee
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by University of Aarhus:
Suture Techniques

Additional relevant MeSH terms:
Wounds and Injuries