Episiotomy, Perineal Lacerations
Conditions
Keywords
Suture Techniques
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.
Interventions
PROCEDURESuture technique for perineal repair after delivery
Sponsors
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
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain in perineal area day 1 and 10 after delivery. | — |
| Healing of wound day 1 and 10 after delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction with perineal sutures performed at birth. | — |
| Incontinence. | — |
| Need for resuturing of perineal area within 1 year after delivery. | — |
Countries
Denmark
Outcome results
None listed