NCT00265421

Study of Different Suturing Techniques for Perineal Repair After Delivery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perineal Lacerations
• Episiotomy

Interventions

Type	Name	Description
PROCEDURE	Suture technique for perineal repair after delivery

Timeline

• Start date: 2004-08-01
• Completion: 2006-04-01
• First posted: 2005-12-14
• Last updated: 2009-09-30

Locations

1 site across 1 country: Denmark