Study of Different Suturing Techniques for Perineal Repair After Delivery

Episiotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265421
• Other study ID #: The Danish Suture Trial
• Secondary ID: 2004-70 Etichs C
• Status: Completed
• Phase: N/A
• First received: December 13, 2005
• Last updated: September 29, 2009
• Start date: August 2004
• Est. completion date: April 2006

Study information

• Verified date: September 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Episiotomy
• Lacerations
• Perineal Lacerations

Intervention

Procedure:
• Suture technique for perineal repair after delivery

Locations

Country	Name	City	State
Denmark	Dept. of Obstetrics and Gynaecology, Skejby Sygehus	Aarhus

Sponsors (9)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Aase and Ejnar Danielsens Foundation, Danish Research Agency, Else and Mogens Wedell-Wedellsborgs´ Foundation, Frode V. Nyegaard and wifes´ Foundation, K.A. Rohde and wifes´ Foundation, Sophus Jacobsen and wifes´ Foundation, The Danish Midwifery Organization

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in perineal area day 1 and 10 after delivery.
Primary	Healing of wound day 1 and 10 after delivery.
Secondary	Patient satisfaction with perineal sutures performed at birth.
Secondary	Incontinence.
Secondary	Need for resuturing of perineal area within 1 year after delivery.