Oral Antibiotics After Obstetric Perineal Tear

NCT05830162 | Completed Phase 4 DMC

• 1 other identifier: 2022-501930-49-00
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Trauma; Infections; Wound Dehiscence

Keywords

obstetric tear; women's health; antibiotics; infection; wound dehiscence

Outcome Measures

Primary Outcomes (2)

• Infection in the obstetric tear

  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.

  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 Outcomes (7)

• 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Antibiotics (bioclavid)

EXPERIMENTAL

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)

Interventions

Placebo DRUG

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

Placebo

Bioclavid (Amoxicillin and Clavulanic acid) DRUG

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

Antibiotics (bioclavid)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Danish speaking women above 18 years
• Second degree perineal tear and/or episiotomy
• Suturing of obstetric tear at Herlev Hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanna Jangö: lead
• Region Hovedstadens Apotek: collaborator

Study Sites (1)

Maternaty ward, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (2)

• Perslev K, Klarskov N, Bergholt T, Jango H. Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial. BMJ. 2025 Oct 29;391:e084312. doi: 10.1136/bmj-2025-084312.

  PMID: 41161737 DERIVED

• Perslev K, Klarskov N, Bergholt T, Jango H. The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear-a double-blinded placebo controlled randomized trial. Trials. 2024 Mar 27;25(1):221. doi: 10.1186/s13063-024-08069-x.

  PMID: 38532503 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Amoxicillin; Clavulanic Acid

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal investigator and sponsor

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: March 21, 2023
• Primary Completion: January 4, 2024
• Study Completion: December 9, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-09

Locations

DK (1)