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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00265421
Study type Interventional
Source University of Aarhus
Contact
Status Completed
Phase N/A
Start date August 2004
Completion date April 2006

See also
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Completed NCT03084549 - Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain Phase 3
Not yet recruiting NCT06415877 - The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training N/A
Recruiting NCT05345600 - MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery N/A
Active, not recruiting NCT02615236 - Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS N/A
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Withdrawn NCT02796547 - Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery Phase 2
Completed NCT02905695 - Post-partum Perineal Pain - Chirocaine® Phase 4
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Completed NCT05486624 - The Effect of Reiki Application on Episiotomy and Perineal Pain N/A
Completed NCT00196508 - A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth Phase 3