Obstetric TraumaPhase 4REPAIRNCT05830162
Oral Antibiotics After Obstetric Perineal Tear
A Phase 4 study testing Bioclavid (Amoxicillin and Clavulanic acid) in people with Obstetric Trauma and Infections, run by Hanna Jangö at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Trauma, Infections, Wound Dehiscence
- What is being tested?
- Bioclavid (Amoxicillin and Clavulanic acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2023to 9 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Danish speaking women above 18 years
- Second degree perineal tear and/or episiotomy
- Suturing of obstetric tear at Herlev Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstetric Trauma, Infections, Wound Dehiscence
- Being tested
- Placebo, Bioclavid (Amoxicillin and Clavulanic acid)
- Keywords
- obstetric tear, women's health, antibiotics, infection, wound dehiscence
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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)Drug
We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bioclavid (Amoxicillin and Clavulanic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Wound dehiscence will be evaluated 1-2 weeks after the delivery
Secondary outcomes (7)
Clinically Relevant Wound Dehiscence
Throughout the study, we noted a high incidence of wound dehiscence, characterized by a separation of wound edges (diastasis) greater than 5 mm. While some cases were minor, superficial, and without signs of infection, others were more severe. To better assess these more significant cases, we introduced a new secondary outcome: clinically relevant wound dehiscence. This classification was applied to wounds for which the clinician assessed that further follow-up was necessary based on the extent of the dehiscence, the severity of pain, or signs of infection
Measured: 1-2 weeks post partum
Pain
Questionnaire with use of Visual Analogue Scale (VAS) from 1-10 with 10 being the worst pain.
Measured: 9-12 months after delivery.
Sexual problems
Questionnaire
Measured: 9-12 months after delivery.
Body image
Questionnaire -
Measured: 9-12 months after delivery.
Number of patients with prolapse
Gynaecological examination
Measured: 9-12 months after delivery.
Prolapse
Questionnaire (asking if the women have had symptoms of prolapse)
Measured: 9-12 months after delivery.
incontinence
Questionnaire
Measured: 9-12 months after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start21 Mar 2023
- Primary completion4 Jan 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstetric TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanna Jangö
- Sponsor type
- University, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Responsible party
- Sponsor-investigator, Hanna Jangö, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830162
- Sponsor's protocol ID
- 2022-501930-49-00
- Acronym
- REPAIR
- Status last verified
- Sep 2024
- First submitted
- 29 Mar 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41161737Perslev 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.
PubMed 38532503
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail
- ClinicalTrials.gov ID
- NCT05830162
- Acronym / sponsor ID
- REPAIR / 2022-501930-49-00
- Conditions
- Obstetric Trauma, Infections, Wound Dehiscence
- Keywords
- obstetric tear, women's health, antibiotics, infection, wound dehiscence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Hanna JangöUniversity, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
| Antibiotics (bioclavid) | Experimental | Drug: Bioclavid (Amoxicillin and Clavulanic acid)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Danish speaking women above 18 years
- Second degree perineal tear and/or episiotomy
- Suturing of obstetric tear at Herlev Hospital
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboWe will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy | Drug | Placebo |
| 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 | Drug | Antibiotics (bioclavid) |
Primary outcome
Infection in the obstetric tear
Time frame: Infection will be evaluated 1-2 weeks after the delivery.
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.
Wound dehiscence
Time frame: 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.
7 secondary outcomes
Clinically Relevant Wound Dehiscence
Time frame: 1-2 weeks post partum
Pain
Time frame: 9-12 months after delivery.
Sexual problems
Time frame: 9-12 months after delivery.
Body image
Time frame: 9-12 months after delivery.
Number of patients with prolapse
Time frame: 9-12 months after delivery.
Prolapse
Time frame: 9-12 months after delivery.
incontinence
Time frame: 9-12 months after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 41161737Perslev 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.
- Derived from this study: PubMed 38532503Perslev 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.
- Individual participant dataSharing planned: Undecided
Related trials for Obstetric Trauma
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioclavid (Amoxicillin and Clavulanic acid) in people with Obstetric Trauma and Infections, run by Hanna Jangö at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection in the obstetric tear (time frame: Infection will be evaluated 1-2 weeks after the delivery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.