Overview
Sponsor-declared trial summary
Obstetric perineal ruptur
To investigate wheather three doses of oral antibiotics given to women with an obstetric perineal wound can reduce the risk of infection and wound dehiscence compared to placebo treatment
Key facts
- Sponsor
- Herlev Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 21 Mar 2023 → 2 Dec 2024
- Decision date (initial)
- 2023-02-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
To investigate wheather three doses of oral antibiotics given to women with an obstetric perineal wound can reduce the risk of infection and wound dehiscence compared to placebo treatment
Conditions and MedDRA coding
Obstetric perineal ruptur
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Women with a second degree tear or an episiotomy of the perineum after a vaginal delivery
- Women above 18 year
- Women wh speaks and read Danish
- Women who are mentally capable of giving informed consent at time of inclusion
- Tear being sutured at Herlev Hospital
Exclusion criteria 3
- Women with allergies towards the used drug
- Women who ends in Caesarean section even though she has a vaginal tear og episiotomy
- Women that for any other reasons recieve antbiotics during or after labour
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of women with perineal infection or wound dehiscence
Secondary endpoints 1
- Number of women with complications after one week and one year. Complications being investigated: incontinence, pelvic prolaps, pain, sexsual dysfunktions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Bioclavid 500 mg/125 mg filmdragerade tabletter
PRD727168 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 14081
- MA holder
- SANDOZ GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herlev Hospital
- Sponsor organisation
- Herlev Hospital
- Address
- Herlev Ringvej 75
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Herlev Hospital
- Contact name
- Hanna Jangö
Public contact point
- Organisation
- Herlev Hospital
- Contact name
- Hanna Jangö
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 442 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-03-21 | 2024-12-02 | 2023-03-22 | 2023-12-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results REPAIR study SUM-98261
|
2025-09-18T10:42:58 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary REPAIR | 2025-09-18T10:46:41 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Plain Language Summary | 1 |
| Summary of results (for publication) | Summary of Results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-13 | Denmark | Acceptable 2022-12-22
|
2023-02-02 |