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Study on Amoxicillin and Clavulanic Acid to Prevent Infection in Women with Obstetric Perineal Tear

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of oral antibiotics on preventing infections and wound complications after an obstetric perineal tear, which is a type of injury that can occur during childbirth. The treatment being tested is a medication called Bioclavid, which contains two active ingredients: amoxicillin and clavulanic acid. These are commonly used antibiotics that help fight bacterial infections. The study will compare the effects of this medication to a placebo, which is a substance with no active ingredients, to see if the antibiotics can reduce the risk of infection and help the wound heal better.

The purpose of the study is to determine whether taking three doses of these oral antibiotics can lower the chances of developing an infection or experiencing wound separation after a perineal tear. Participants in the study will be randomly assigned to receive either the antibiotics or the placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, researchers will monitor the participants for any signs of infection or wound complications. They will also check for any other issues that might arise, such as incontinence, pelvic prolapse, pain, or sexual dysfunction, both one week and one year after the treatment. The study aims to provide valuable information on whether antibiotics can be an effective way to prevent complications after childbirth-related perineal tears.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be women with a second-degree tear or an episiotomy of the perineum after a vaginal delivery, above 18 years old, able to speak and read Danish, mentally capable of giving informed consent, and have had the tear sutured at Herlev Hospital.

  2. Step 2

    Receiving medication

    Participants are randomly assigned to receive either the antibiotic or a placebo. The antibiotic used is a combination of amoxicillin and clavulanic acid, provided in the form of film-coated tablets named Bioclavid 500 mg/125 mg.

    The medication is taken orally in three doses. The exact dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Participants are monitored for any signs of infection or wound dehiscence. The primary goal is to assess the number of women experiencing these issues.

    Secondary observations include monitoring for complications such as incontinence, pelvic prolapse, pain, and sexual dysfunction after one week and one year.

  4. Step 4

    Completion of the study

    The study is expected to conclude by February 1, 2026. Participants will have completed all required follow-ups and assessments by this date.

Who can join the trial?

5 criteria

  • Women with a second degree tear or an episiotomy of the perineum after a vaginal delivery. A second degree tear is a tear that involves the vaginal tissue and the muscle beneath it. An episiotomy is a surgical cut made at the opening of the vagina during childbirth.
  • Women above 18 years old.
  • Women who speak and read Danish.
  • Women who are mentally capable of giving informed consent at the time of inclusion. Informed consent means understanding the details of the study and agreeing to participate.
  • The tear must be sutured at Herlev Hospital.

Who cannot join the trial?

4 criteria

  • Women who are not experiencing an obstetric perineal rupture cannot participate. This refers to a tear in the area between the vagina and anus that can occur during childbirth.
  • Men cannot participate in this study.
  • Women who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
  • Individuals who are considered part of a vulnerable population may not be eligible. This term generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Oral antibiotics are medications used to fight infections caused by bacteria. In this clinical trial, they are given to women who have experienced a tear in the perineal area during childbirth. The goal is to see if taking these antibiotics can help prevent infections and help the wound heal better. The antibiotics work by stopping the growth of bacteria, which can reduce the risk of the wound becoming infected and help it heal properly.

What is already known about the treatment

Oral antibiotics – Oral antibiotics are medications taken by mouth to help prevent infections. In the context of this clinical trial, they are being studied to see if they can reduce the risk of infection and wound reopening in women who have experienced a tear during childbirth. These antibiotics work by targeting and killing bacteria that can cause infections. They are classified as antibacterial agents and are commonly used to treat or prevent bacterial infections.

Investigated diseases

Obstetric perineal rupture – This condition occurs during childbirth when the tissue between the vagina and the anus tears. It can vary in severity, from minor tears involving only the skin to more severe tears affecting the muscles and tissues. The healing process can be slow, and complications may arise if the wound becomes infected or does not heal properly. In some cases, women may experience discomfort, pain, or issues with bowel movements during recovery. Over time, the tissue generally heals, but some women may experience long-term effects such as incontinence or pelvic floor dysfunction. Proper care and monitoring are essential to ensure optimal healing and to minimize complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501930-49-00Estimated enrolment442 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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