Episiotomy Clinical Trial
Official title:
The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
Verified date | September 2009 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Obstetrics and Gynaecology, Skejby Sygehus | Aarhus |
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 |
Denmark,
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. |
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