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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
Est. primary completion date
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


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.
See also
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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
Recruiting NCT02847936 - Efficacy of Triclosan-coated Sutures in the Episiotomy Phase 4
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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