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Completed

NCT Number: NCT00265421

Study of Different Suturing Techniques for Perineal Repair After Delivery

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.

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Key information

Conditions

Perineal Lacerations Episiotomy

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Obstetrics and Gynaecology, Skejby Sygehus

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suture technique for perineal repair after delivery

Procedure

Primary outcomes

  1. Pain in perineal area day 1 and 10 after delivery.

  2. Healing of wound day 1 and 10 after delivery.

Secondary outcomes

  1. Patient satisfaction with perineal sutures performed at birth.

  2. Incontinence.

  3. Need for resuturing of perineal area within 1 year after delivery.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • 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's and wife's Foundation
  • Sophus Jacobsen and wifes´ Foundation
  • The Danish Midwifery Organization

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Dec 14, 2005
Registry last updated
Sep 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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