Not Yet RecruitingPhase 4ACTRN12619000018112

The Impact of Azithromycin on Surgical Site Infection Rates

The Impact of Azithromycin on Surgical Site Infection Rates (TIASSIR) in pregnant women undergoing an emergency Caesarean section at Redland Hospital


Sponsor

Obstetrics & Gynaecology Department, Redland Hospital

Enrollment

385 participants

Start Date

Feb 11, 2019

Study Type

Interventional

Conditions

Summary

A randomized controlled trial is designed to assess the impact of Azithromycin in reducing infectious morbidity from emergency cesarean sections at Redlands Hospital. The population undergoing emergency cesarean sections will be the focus of the research project. Adding Azithromycin to the pre-operative antibiotic regime (of Intravenous Cefazolin and topical Iodine Vaginal Cleansing) is hypothesized to be more effective at reducing post-caesarean section infection rates than the current standard pre-operative antibiotic regime alone.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • Singleton pregnancy AND
  • Equal to or more than 32 weeks pregnant AND
  • Emergency lower segment Cesarean section (LSCS) either in labour (defined as regular painful contractions AND progressive cervical dilatation of at least 4cm OR Rupture of Membranes >4 hours OR meeting both criteria)

Exclusion Criteria6

  • Elective lower segment Caesar section OR
  • Azithromycin/ Iodine/ Cefazolin allergy OR
  • Inability to provide or declined consent OR
  • Multiple pregnancy OR
  • On antibiotics for any other reasons within 7 days of labour OR
  • Azithromycin/ Iodine/ Cefazolin medically contraindicated

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Interventions

Intervention Group will receive: 1. Intravenous Cefazolin (2g if patient weight at delivery <120kg/ 3g if patient weight at delivery >120kg) AND 2. Intravenous Azithromycin 500mg AND 3. Topical Iod

Intervention Group will receive: 1. Intravenous Cefazolin (2g if patient weight at delivery <120kg/ 3g if patient weight at delivery >120kg) AND 2. Intravenous Azithromycin 500mg AND 3. Topical Iodine vaginal preparation The intravenous antibiotics will be administered, within 15-60 minutes of skin incision (commenced prior to skin incision); the topical iodine will be applied after adequate anaesthesia is achieved but prior to skin incision


Locations(1)

Redland Hospital - Cleveland

QLD, Australia

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