Prophylaxis (antibiotics) during maternal or fetal surgery
Conditions
Brief summary
A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints.
Detailed description
Pharmacokinetic analysis, including the covariates of interest or relevant clinical characteristics i.e., body weight, length, age, body surface area (BSA), gestational age, type of delivery, intercurrent co-morbidity (e.g., renal and hepatic dysfunction, hypothermia, hypothyroidism), other parenteral or other co-medications.
Interventions
DRUGDalacin C 600 mg solution injectable
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic analysis, including the covariates of interest or relevant clinical characteristics i.e., body weight, length, age, body surface area (BSA), gestational age, type of delivery, intercurrent co-morbidity (e.g., renal and hepatic dysfunction, hypothermia, hypothyroidism), other parenteral or other co-medications. | — |
Primary
| Measure | Time frame |
|---|---|
| A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints. | — |
Countries
Belgium
Outcome results
None listed