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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-70 Etichs Committee |
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| Name | Class |
|---|---|
| Danish Research Agency | OTHER |
| Aase and Ejnar Danielsens Foundation | OTHER |
| Aarhus University Hospital | OTHER |
| The Danish Midwifery Organization |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture technique for perineal repair after delivery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in perineal area day 1 and 10 after delivery. | ||
| Healing of wound day 1 and 10 after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with perineal sutures performed at birth. | ||
| Incontinence. | ||
| Need for resuturing of perineal area within 1 year after delivery. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Niels Uldbjerg, Professor | Aarhus University Hopspital, dept. of Obst. & Gyn. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Obstetrics and Gynaecology, Skejby Sygehus | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D013536 | Suture Techniques |
| ID | Term |
|---|---|
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
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| UNKNOWN |
| Sophus Jacobsen and wifes´ Foundation | UNKNOWN |
| Else and Mogens Wedell-Wedellsborgs´ Foundation | UNKNOWN |
| Frode V. Nyegaard and wifes´ Foundation | UNKNOWN |
| K. A. Rohde's and wife's Foundation | OTHER |
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