Study of Different Suturing Techniques for Perineal Repair After Delivery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Perineal Lacerations Episiotomy |
Procedure: Suture technique for perineal repair after delivery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth. |
- Pain in perineal area day 1 and 10 after delivery.
- Healing of wound day 1 and 10 after delivery.
- Patient satisfaction with perineal sutures performed at birth.
- Incontinence.
- Need for resuturing of perineal area within 1 year after delivery.
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | April 2006 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Denmark | |
| Dept. of Obstetrics and Gynaecology, Skejby Sygehus | |
| Aarhus, Denmark, 8200 | |
| Study Chair: | Niels Uldbjerg, Professor | Aarhus University Hopspital, dept. of Obst. & Gyn. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00265421 History of Changes |
| Other Study ID Numbers: | The Danish Suture Trial, 2004-70 Etichs Committee |
| Study First Received: | December 13, 2005 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by University of Aarhus:
|
Suture Techniques |
Additional relevant MeSH terms:
|
Lacerations Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013