REPAIR: Oral Antibiotics After Obstetric Perineal Tear

Sponsor

Hanna Jangö (Other)

Overall Status

Recruiting

CT.gov ID

NCT05830162

Collaborator

Region Hovedstadens Apotek (Other)

442

Enrollment

Location

Arms

23.4

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstetric Trauma Infections Wound Dehiscence	Drug: Placebo Drug: Bioclavid (Amoxicillin and Clavulanic acid)	Phase 4

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.

The primary outcome is wound dehiscence and/or wound infection, which will be calculated using χ2-tests to compare groups. Secondary outcomes are variables that relate to wound healing, for example pain, use of painkillers, need for further follow-up, as well as other outcomes that may be related to the birth or healing process; urinary or anal incontinence, symptoms of prolapse, female body image and sexual problems.

Discussion:

Reducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment and possibly also decrease both short-term and long-term symptoms. This would be of great importance since the period after a delivery is a crucial time for the whole family.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

442 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail

Actual Study Start Date :

Mar 21, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: Placebo We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy
Experimental: 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.	Drug: Bioclavid (Amoxicillin and Clavulanic acid) We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy

Arm

Intervention/Treatment

Placebo Comparator: 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.

Drug: Placebo

We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy

Experimental: 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.

Drug: Bioclavid (Amoxicillin and Clavulanic acid)

We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy

Outcome Measures

Primary Outcome Measures

Infection in the obstetric tear [Infection will be evaluated 1-2 weeks after the delivery.]
We use the REEDA criteria for estimating of this outcome: Redness, Edema, Ecchymosis, Discharge, Approximation.
Wound dehiscence [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 Outcome Measures

Pain [9-12 months after delivery.]
Questionnaire with use of Visual Analogue Scale (VAS) from 1-10 with 10 being the worst pain.
Sexual problems [9-12 months after delivery.]
Questionnaire
Body image [9-12 months after delivery.]
Questionnaire -
Number of patients with prolapse [9-12 months after delivery.]
Gynaecological examination
Prolapse [9-12 months after delivery.]
Questionnaire (asking if the women have had symptoms of prolapse)
incontinence [9-12 months after delivery.]
Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.