Episiotomy Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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