Study of Different Suturing Techniques for Perineal Repair After Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.

Conditions
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Episiotomy, Perineal Lacerations

Intervention / Treatment
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* Procedure: Suture technique for perineal repair after delivery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Suture technique for perineal repair after delivery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in perineal area day 1 and 10 after delivery. |  |  | 
| Healing of wound day 1 and 10 after delivery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with perineal sutures performed at birth. |  |  | 
| Incontinence. |  |  | 
| Need for resuturing of perineal area within 1 year after delivery. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suture Techniques