Study of Different Suturing Techniques for Perineal Repair After Delivery

Not Applicable

Completed

• Conditions: Perineal Lacerations; Episiotomy

• Registration Number: NCT00265421
• Lead Sponsor: University of Aarhus

Brief 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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-14
• Study Completion: 2006-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-29
• Last Update Posted: 2009-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.

Exclusion Criteria

Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain in perineal area day 1 and 10 after delivery.
Healing of wound day 1 and 10 after delivery.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with perineal sutures performed at birth.
Incontinence.
Need for resuturing of perineal area within 1 year after delivery.

Trial Locations

Locations (1)

Dept. of Obstetrics and Gynaecology, Skejby Sygehus; 🇩🇰 Aarhus, Denmark