Study of Different Suturing Techniques for Perineal Repair After Delivery
Primary Purpose
Perineal Lacerations, Episiotomy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Suture technique for perineal repair after delivery
Sponsored by
About this trial
This is an interventional treatment trial for Perineal Lacerations focused on measuring Suture Techniques
Eligibility 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.
Sites / Locations
- Dept. of Obstetrics and Gynaecology, Skejby Sygehus
Outcomes
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.
Full Information
NCT ID
NCT00265421
First Posted
December 13, 2005
Last Updated
September 29, 2009
Sponsor
University of Aarhus
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's and wife's Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00265421
Brief Title
Study of Different Suturing Techniques for Perineal Repair After Delivery
Official Title
The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
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's and wife's Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Lacerations, Episiotomy
Keywords
Suture Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Suture technique for perineal repair after delivery
Primary Outcome Measure Information:
Title
Pain in perineal area day 1 and 10 after delivery.
Title
Healing of wound day 1 and 10 after delivery.
Secondary Outcome Measure Information:
Title
Patient satisfaction with perineal sutures performed at birth.
Title
Incontinence.
Title
Need for resuturing of perineal area within 1 year after delivery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Uldbjerg, Professor
Organizational Affiliation
Aarhus University Hopspital, dept. of Obst. & Gyn.
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Obstetrics and Gynaecology, Skejby Sygehus
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Study of Different Suturing Techniques for Perineal Repair After Delivery
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