Oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear - a double-blinded placebo controlled randomized trail

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501930-49-00

Enrollment

442

Registered

2023-02-02

Start date

2023-03-21

Completion date

2024-12-02

Last updated

2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric perineal ruptur

Brief summary

Number of women with perineal infection or wound dehiscence

Detailed description

Number of women with complications after one week and one year. Complications being investigated: incontinence, pelvic prolaps, pain, sexsual dysfunktions

Interventions

DRUGBioclavid 500 mg/125 mg filmdragerade tabletter

DRUGPlacebo

DRUG17 mm delekærv

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Number of women with perineal infection or wound dehiscence	—

Secondary

Measure	Time frame
Number of women with complications after one week and one year. Complications being investigated: incontinence, pelvic prolaps, pain, sexsual dysfunktions	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 8, 2026