None listed
Conditions
Brief summary
This feasibility study is a preliminary step in the planning of a multicenter randomized controlled trial (RCT), assessing the influence of placebo versus cefazolin on the incidence of neonatal and childhood atopic diseases. The primary outcome will be the incidence of infant allergic disease assessed using parental questionnaires based on modified Barwon Infant Study questionnaires. A composite outcome based on the presence of atopic dermatitis/eczema; the presence of food allergy and the presence of recurrent wheeze, in the first 12 months of life. A secondary aim is to demonstrate feasibility as well as acceptability of the concept to patients and clinicians. We will also collect a range of biological samples (maternal and neonatal) for preliminary microbiological and immunological analysis, to assess the impact of pre-delivery cefazolin. This will guide targeted biological sample collection in the subsequent RCT.
Interventions
Single intravenous pre-operative dose. 2 grams of cefazolin will be prepared in 100 mL of normal saline, with opaque labelling such that the contents of the bag cannot be visualized, exactly the same as the placebo. After administration over 1-2 minutes, it will be “flushed through” with a second 100 ml bag of labelled normal saline 0.9%.
The intervention will be administered within 30 minutes of skin incision.
Nurse notes will document preparation (unblinded nurse)
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
Scheduled for elective caesarean section. Age < 40 years and greater than or equal to 18 years, gestation greater than 37 weeks, membranes intact, body mass index less than 25, not in labour, non-smoking, haemoglobin greater than 110g/L, non-diabetic, (Type 1, Type 2 or gestational diabetes) American Society of Anesthesiologists score (ASA score) = 2. (The ASA score is classification of physical status: 1 being a healthy patient, 5 being a moribund patient and 6 being an organ donor. Pregnancy is classified as a minimum score of 2.)
Exclusion criteria
Allergy to cephalosporin antibiotics, allergy to chlorhexidine, conditions pre-disposing to haemorrhage (anticoagulation, thrombocytopaenia, abnormal placentation) conditions pre-disposing to infection (immunosuppression, autoimmune disorders, steroid use), complex cardiac or respiratory disease, classical uterine incision (vertical), use of a wound drain, manual removal of placenta.
Outcome results
None listed