Perineal Tears.
Conditions
Keywords
Delivery tears, Birth injuries, Perineal protection device
Brief summary
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
Detailed description
RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.
Interventions
DEVICEPerineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Sponsors
Knut Haadem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Vaginal delivery at term (week 36 - 41)
Exclusion criteria
* Age below 18 * Breech delivery * Not understanding written and oral information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of delivery tear measured in cm with ruler | at delivery - Participants will be followed for the duration of the first 24 hours | The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of the device on mother and child | at delivery-Participants will be followed for the duration of the first 24 hours | Measure eventual adverse effects on mother and child. |
Countries
Sweden
Contacts
Primary ContactKnut Haadem, M.D. PhD
Backup ContactTony Lavesson, M.D
Outcome results
None listed