Study of Different Suturing Techniques for Perineal Repair After Delivery
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.
Procedure: Suture technique for perineal repair after delivery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.|
- Pain in perineal area day 1 and 10 after delivery.
- Healing of wound day 1 and 10 after delivery.
- Patient satisfaction with perineal sutures performed at birth.
- Need for resuturing of perineal area within 1 year after delivery.
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||April 2006|
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.
|Dept. of Obstetrics and Gynaecology, Skejby Sygehus|
|Aarhus, Denmark, 8200|
|Study Chair:||Niels Uldbjerg, Professor||Aarhus University Hopspital, dept. of Obst. & Gyn.|