BMI-related Postsurgical prophylaxis after caesarean section
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Older than 18 years of age 2) Admitted at the Department of Obstetrics at Erasmus MC - Sophia for caesarean section. 3) Understanding of Dutch in speaking and reading. 4) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Women unable or unwilling to agree with the procedures. 2) Women unable or unwilling to give written informed consent. 3) Women with acute obstetric complications requiring immediate delivery at time of admission. 4) Women with interacting drugs, this can influence PK.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the maternal pharmacokinetics of standard antibiotic regimen admitted at the Department of Obstetrics at the Erasmus MC - Sophia for antibiotic treatment for postsurgical prophylaxis after caesarean section. Farmacokinetic parameters, which will be determined are: distribution (VD), clearance (Cl), elimination-rate constant (kel), steady-state concentration (Css), half-life (t1/2), bioavailability (F). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To examine the relation between the weight category (1. BMI 40) before conception and the pharmacokinetics of the antibiotic regimen (primary objective). 2. To examine the relation between the gestational age (weeks) and the pharmacokinetics of the antibiotic regimen (primary objective). 3. To examine the relation between maternal age (years) and the pharmacokinetics of the antibiotic regimen (primary objective). 4. To examine the relation between fetal sex and the pharmacokinetics of the antibiotic regimen (primary objective). 5. To examine the relation between maternal SNPs in cytochrome P450 isoenzyme genes and the pharmacokinetics of the antibiotic regimen (primary objective). | — |
Countries
Netherlands
Outcome results
None listed