ClinicalTrials.gg
Status unknownNCT00162604Updated Sep 11, 2006

Prophylactic Antibiotic Treatment During Vaginal Repair

An interventional study of Cefuroxime in Uterine Prolapse, Cystocele and Rectocele, sponsored by Hvidovre University Hospital. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-09-11.

Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.

The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.

02

Conditions studied

  • Uterine Prolapse
  • Cystocele
  • Rectocele
  • Enterocele

Keywords

  • Prophylactic antibiotic
  • Postoperative infections
  • Uterine prolapse grade I - II
  • cystocele
  • rectocele
  • enterocele
  • defects of the perineal body
03

In context

Uterine Prolapse

111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.

This study's enrollment of 200 is above the median of 70 across 76 interventional studies indexed under Uterine Prolapse.

Browse Uterine Prolapse studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.

Exclusion criteria

Exclusion Criteria:

  • Patients allergic to cefuroxime.
  • Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.
  • Patients suffering from physical or mental disorders that will not allow them to give .
  • Pregnant and nursing women.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

06

What researchers measure

Primary outcomes

  1. primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively

07

Study locations

1 of 1 sites recruiting
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
    Recruiting
    • Marianne Ottesen, M.D · Contactmarianne.8sen@dadlnet.dk · 0045 36323632
    • Tina Olsen, M.D · Sub investigator
    • Abelone Elisabeth Sakse, M.D · Sub investigator
    • Marianne Ottesen, M.D, PhD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00162604
First posted
Sep 13, 2005
Start date
May 2005
Last update
Sep 11, 2006

Study contacts

Marianne Ottesen, M.D
Contact
marianne.8sen@dadlnet.dk
0045 36323632 ext. 3540
Marianne Ottesen, M.D, Ph.D
study director · Hvidovre University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cefuroxime

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