Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 442
- Locations
- 1
- Primary Endpoint
- Infection in the obstetric tear
Study Overview
Brief Summary
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.
Detailed Description
Background:
Obstetric tear occurs in more than 90% of nulliparous women and up to 25% subsequently experience wound dehiscence and/or infection. Some data shows that intravenous antibiotics given during delivery reduces this risk. It is unknown if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection.
The study-goupe want to investigate whether three doses of antibiotics (amoxicillin 500 mg / clavulanic acid 125 mg) given after delivery can reduce the risk of wound dehiscence and infection.
Methods:
The investigators will perform a randomized, controlled, double-blinded study and plan to include 221 women in each arm with allocation 1:1 in relation to the randomization. The study is carried out at Department of Obstetrics & Gynecology, Herlev University Hospital, Copenhagen, Denmark. The women will be included after delivery if they have had a second-degree tear or episiotomy. The first tabelt has to be taken with in 6 hours from the delivery. After inclusion, the women will have a clinical follow up visit after one week. The tear and healing will be evaluated regarding infection and/or dehiscence. The women will again be invited for a one year clinical examination including ultrasound. Questionaries exploring symptoms related to the vaginal tear and possible complications will be answered at both visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Antibiotics (bioclavid)
The Pharmacy of the main capital region provides the bioclavid (amoxicillin with Clavulanic acid) and placebo tablets for this study. They are responsible for the randomization and packing of the tablets. The randomization will be in randomly varying block sizes.
Women in the antibiotic arm will get 3 tablets bioclavid (amoxicillin and Clavulanic acid) to take within the fist 24 hours of the delivery. The first tablet must be administrated within 6 hours of the delivery.
Intervention: Bioclavid (Amoxicillin and Clavulanic acid) (Drug)
Placebo
The Pharmacy of the main capital region provides the bioclavid (amoxicillin with Clavulanic acid) and placebo tablets for this study. They are responsible for the randomization and packing of the tablets. The randomization will be in randomly variating block sizes.
Women in the placebo arm will get 3 calcium tablets to take within the fist 24 hours of the delivery. The first tablet must be administrated within 6 hours of the delivery.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Infection in the obstetric tear
Time Frame: Infection will be evaluated 1-2 weeks after the delivery.
We used the REEDA criteria-Redness, Edema, Ecchymosis, Discharge, and Approximation-to assess this outcome. However, we only diagnosed infection in cases where there was clear clinical evidence, in this study defined as the presence of an abscess or significant wound discharge. In instances of pronounced redness, edema, ecchymosis, or smaller amounts of discharge, these findings were recorded as possible infection or possible resolved infection in the patient's notes as observational comment.
Wound dehiscence
Time Frame: Wound dehiscence will be evaluated 1-2 weeks after the delivery
We will measure the amount of dehiscence and if above 5 mm it will be diagnoses as a wound dehiscence.
Secondary Outcomes
- Clinically Relevant Wound Dehiscence(1-2 weeks post partum)
- Pain(9-12 months after delivery.)
- Sexual problems(9-12 months after delivery.)
- Body image(9-12 months after delivery.)
- Number of patients with prolapse(9-12 months after delivery.)
- Prolapse(9-12 months after delivery.)
- incontinence(9-12 months after delivery.)
Investigators
Hanna Jangö
Prinicipal investigator and sponsor
Herlev Hospital