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| ID | Type | Description | Link |
|---|---|---|---|
| ONLY-HBG | Registry Identifier | KH-HBG-13 |
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The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal device during delivery | Active Comparator | Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand. |
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| Standard care | Other | Standard care at delivery: Manual support of the perineum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal protection device. | Device | A device used to reduce perineal tears during delivery of the baby. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of delivery tear measured in cm with ruler | The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery. | at delivery - Participants will be followed for the duration of the first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of the device on mother and child | Measure eventual adverse effects on mother and child. | at delivery-Participants will be followed for the duration of the first 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Knut Haadem, M.D. PhD | Contact | 0046739549946 | knut.haadem@telia.se | |
| Tony Lavesson, M.D | Contact | 0046424062205 | tony.lavesson@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Knut Haadem, M.D., PhD | Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Obstetrics and Gynecology, Helsingborg Hospital | Recruiting | Helsingborg | Skåne County | 20587 | Sweden |
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| ID | Term |
|---|---|
| D001720 | Birth Injuries |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
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