Clinical trial

Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail

Name

2022-501930-49-00

Description

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.

Trial arms

Trial start

2023-03-21

Estimated PCD

2024-06-01

Trial end

2025-03-01

Status

Recruiting

Phase

Early phase I

Treatment

Placebo

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

Arms:

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

Arms:

Antibiotics (bioclavid)

Size

442

Primary endpoint

Infection in the obstetric tear

Infection will be evaluated 1-2 weeks after the delivery.

Wound dehiscence

Wound dehiscence will be evaluated 1-2 weeks after the delivery

Eligibility criteria

Inclusion Criteria: * Danish speaking women above 18 years * Second degree perineal tear and/or episiotomy * Suturing of obstetric tear at Herlev Hospital Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 442, 'type': 'ESTIMATED'}}

Updated at

2023-04-28

1 organization

1 product

1 drug

3 indications

Organization

Drug

Indication

Indication

Indication

Product