Oral Antibiotics After Obstetric Perineal Tear (REPAIR)

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Wound Dehiscence; Obstetric Trauma
• Intervention / Treatment: Drug: Placebo; Drug: Bioclavid (Amoxicillin and Clavulanic acid)

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 Type: Interventional
• Enrollment (Anticipated): 442
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hanna M Jangö, MD, PhD; Phone Number: 38381612; Email: hanna.margareta.jangoe@regionh.dk
• Study Contact Backup: Name: Kathrine Perslev, MD, PhD student; Phone Number: 38696799; Email: kathrine.perslev@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Maternaty ward, Herlev Hospital
    • Contact: Hanna M Jangö, MD; Phone Number: +45 38381612; Email: hanna.margareta.jangoe@regionh.dk
    • Contact: Kathrine Perslev, MD; Phone Number: +45 38696799; Email: kathrine.perslev@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanna Jangö
• Collaborators: Region Hovedstadens Apotek

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: infection; women's health; antibiotics; wound dehiscence; obstetric tear
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids
• Other Study ID Numbers: 2022-501930-49-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No