Infections Clinical Trial
— REPAIROfficial title:
Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail
The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence compared to women with 3 doses of placebo treatment.
Status | Recruiting |
Enrollment | 442 |
Est. completion date | March 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Danish speaking women above 18 years - Second degree perineal tear and/or episiotomy - Suturing of obstetric tear at Herlev Hospital Exclusion Criteria: - Allergies to the treatment. - Women who end up with a cesarean-section, including those who have obstetric tears that require stitching or have had an episiotomy - Women who receive antibiotics intra- or postpartum for other reasons. |
Country | Name | City | State |
---|---|---|---|
Denmark | Maternaty ward, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Hanna Jangö | Region Hovedstadens Apotek |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infection in the obstetric tear | We use the REEDA criteria for estimating of this outcome: Redness, Edema, Ecchymosis, Discharge, Approximation. | Infection will be evaluated 1-2 weeks after the delivery. | |
Primary | Wound dehiscence | We will measure the amount of dehiscence and if above 5 mm it will be diagnoses as a wound dehiscence. | Wound dehiscence will be evaluated 1-2 weeks after the delivery | |
Secondary | Pain | Questionnaire with use of Visual Analogue Scale (VAS) from 1-10 with 10 being the worst pain. | 9-12 months after delivery. | |
Secondary | Sexual problems | Questionnaire | 9-12 months after delivery. | |
Secondary | Body image | Questionnaire - | 9-12 months after delivery. | |
Secondary | Number of patients with prolapse | Gynaecological examination | 9-12 months after delivery. | |
Secondary | Prolapse | Questionnaire (asking if the women have had symptoms of prolapse) | 9-12 months after delivery. | |
Secondary | incontinence | Questionnaire | 9-12 months after delivery. |
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