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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000018112

Acronym

TIASSIR

Enrollment

385

Registered

2019-01-09

Start date

2019-02-11

Completion date

2020-02-29

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results