An interventional study of Azithromycin Pill + Cefuroxime and Placebo + Cefuroxime in Infection Post Op, Hysterectomy and Antibiotics, sponsored by Helsinki University Central Hospital. Recruiting at 6 sites in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Prevention
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 2,278 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Changed with renewed study permissions: These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision. The previous description: These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision.
Drug: Azithromycin Pill + Cefuroxime
Changed with new study permissions: These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision. The previous description: These patients will receive placebo (2 tablets) per orally in the evening before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision.
Drug: Placebo + Cefuroxime
Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Placebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Number of post-hysterectomy episodes with deep infections
Number of deep wound and pelvic organ infection episodes reported by patients and doctors
Time frame: Deep infections that occur between the first and 30th postoperative day after hysterectomy
Number of other post-hysterectomy infections or fever episodes
Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days
Time frame: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Helsinki University Central Hospital →