Status:
COMPLETED
Study of Different Suturing Techniques for Perineal Repair After Delivery
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Danish Research Agency
Aase and Ejnar Danielsens Foundation
Conditions:
Perineal Lacerations
Episiotomy
Eligibility:
FEMALE
15-45 years
Phase:
NA
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 health...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00265421
Start Date
August 1 2004
End Date
April 1 2006
Last Update
September 30 2009
Active Locations (1)
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1
Dept. of Obstetrics and Gynaecology, Skejby Sygehus
Aarhus, Denmark, 8200