Oral Antibiotics After Obstetric Perineal Tear

Infections Clinical Trial

— REPAIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830162
• Other study ID #: 2022-501930-49-00
• Status: Recruiting
• Phase: Phase 4
• Start date: March 21, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Herlev Hospital
• Contact: Hanna M Jangö, MD, PhD
• Phone: 38381612
• Email: hanna.margareta.jangoe[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Infections
• Obstetric Trauma
• Wound Dehiscence

Intervention

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

Locations

Country	Name	City	State
Denmark	Maternaty ward, Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Hanna Jangö	Region Hovedstadens Apotek

Country where clinical trial is conducted

Denmark, 

Outcome

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.