Study of Different Suturing Techniques for Perineal Repair After Delivery
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|ClinicalTrials.gov Identifier: NCT00265421|
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : September 30, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Perineal Lacerations Episiotomy||Procedure: Suture technique for perineal repair after delivery||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.|
|Study Start Date :||August 2004|
|Study Completion Date :||April 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265421
|Dept. of Obstetrics and Gynaecology, Skejby Sygehus|
|Aarhus, Denmark, 8200|
|Study Chair:||Niels Uldbjerg, Professor||Aarhus University Hopspital, dept. of Obst. & Gyn.|