Hanadi H Alrammaal1,2, Hannah K Batchelor3,4, Hsu P Chong5,6, Victoria Hodgetts Morton6,7, R Katie Morris6,7. 1. School of Pharmacy, Institute of Clinical Sciences, Robert Aitken Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. hrammaal@uqu.edu.sa. 2. Clinical Pharmacy Department, College of Pharmacy, Umm Al-Qura University, Makkah, Makkah Province, Saudi Arabia. hrammaal@uqu.edu.sa. 3. School of Pharmacy, Institute of Clinical Sciences, Robert Aitken Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. 4. Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow, G4 0RE, UK. 5. Rosie Maternity Hospital, Robinson Way, Cambridge, CB2 0SQ, UK. 6. Department of Fetal and Maternal Medicine, Birmingham Women's and Children's NHS Foundation Trust, Edgbaston, Birmingham, B15 2TG, UK. 7. Institute for Metabolic and Systems Research, University of Birmingham, Birmingham, UK.
Abstract
BACKGROUND: The aim of the C-LACE study is to measure cefuroxime concentration in plasma and adipose tissue of non-obese and obese pregnant women undergoing caesarean section. METHODS: This study plans to compare maternal cefuroxime concentrations (plasma and adipose tissue), at the time of skin incision and time of skin closure during a caesarean section from non-obese (body mass index BMI < 30 kg/m2) and obese (BMI ≥ 30 kg/m2) pregnant women. The incidence of post-surgical site infection will also be measured. At least 15 participants are required for each arm (non-obese vs obese) with a total of 30 participants. The study participants will be followed up between 30 and 40 days post-caesarean section to record details of any post-caesarean surgical infection to explore correlations between BMI, measured cefuroxime concentrations and post-caesarean infection rates. DISCUSSION: This pilot study will allow the development of a model testing the inter-patient variability in plasma and adipose tissue concentrations of cefuroxime. The results will facilitate the development of a larger study to determine whether differences in cefuroxime plasma and tissue concentration in obese and non-obese women can support the development of a physiologically based pharmacokinetic model. This model can then be used to propose dosing adjustments that can be used in a further trial to optimise cefuroxime dosing for women undergoing caesarean section. TRIAL REGISTRATION: ISRCTN Registry , ISRCTN17527512 . Registered on 26 October 2020.
BACKGROUND: The aim of the C-LACE study is to measure cefuroxime concentration in plasma and adipose tissue of non-obese and obese pregnant women undergoing caesarean section. METHODS: This study plans to compare maternal cefuroxime concentrations (plasma and adipose tissue), at the time of skin incision and time of skin closure during a caesarean section from non-obese (body mass index BMI < 30 kg/m2) and obese (BMI ≥ 30 kg/m2) pregnant women. The incidence of post-surgical site infection will also be measured. At least 15 participants are required for each arm (non-obese vs obese) with a total of 30 participants. The study participants will be followed up between 30 and 40 days post-caesarean section to record details of any post-caesarean surgical infection to explore correlations between BMI, measured cefuroxime concentrations and post-caesarean infection rates. DISCUSSION: This pilot study will allow the development of a model testing the inter-patient variability in plasma and adipose tissue concentrations of cefuroxime. The results will facilitate the development of a larger study to determine whether differences in cefuroxime plasma and tissue concentration in obese and non-obese women can support the development of a physiologically based pharmacokinetic model. This model can then be used to propose dosing adjustments that can be used in a further trial to optimise cefuroxime dosing for women undergoing caesarean section. TRIAL REGISTRATION: ISRCTN Registry , ISRCTN17527512 . Registered on 26 October 2020.
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