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Clinical Trials/2022-501930-49-00
2022-501930-49-00CompletedPhase 4

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

Herlev Hospital1 site in 1 country442 target enrollmentStarted: February 2, 2023Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
442
Locations
1
Primary Endpoint
Number of women with perineal infection or wound dehiscence
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Eligibility Criteria

Ages
18 years to 64 years (18-64 Years)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

  • •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

Outcomes

Primary Outcomes

Number of women with perineal infection or wound dehiscence

Number of women with perineal infection or wound dehiscence

Secondary Outcomes

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

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Hanna Jangö

Scientific

Herlev Hospital

Study Sites (1)

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