- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265421
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8200
- Dept. of Obstetrics and Gynaecology, Skejby Sygehus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain in perineal area day 1 and 10 after delivery.
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Healing of wound day 1 and 10 after delivery.
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Secondary Outcome Measures
Outcome Measure |
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Patient satisfaction with perineal sutures performed at birth.
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Incontinence.
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Need for resuturing of perineal area within 1 year after delivery.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Niels Uldbjerg, Professor, Aarhus University Hopspital, dept. of Obst. & Gyn.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- The Danish Suture Trial
- 2004-70 Etichs Committee
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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