Difference in pharmacokinetics of antibiotics during pregnancy in normal, overweight and obese women.

Phase 4

Recruiting

Conditions: BMI-related
Postsurgical prophylaxis after caesarean section
antibiotic treatment
10010273

Registration Number: NL-OMON52470

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To examine the maternal pharmacokinetics of standard antibiotic regimen<br /><br>admitted at the Department of Obstetrics at the Erasmus MC - Sophia for<br /><br>antibiotic treatment for postsurgical prophylaxis after caesarean section.<br /><br>Farmacokinetic parameters, which will be determined are: distribution (VD),<br /><br>clearance (Cl), elimination-rate constant (kel), steady-state concentration<br /><br>(Css), half-life (t1/2), bioavailability (F).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To examine the relation between the weight category (1. BMI <25, 2. BMI<br /><br>25-<30, 3. BMI 30-40, 4. BMI >40) before conception and the pharmacokinetics of<br /><br>the antibiotic regimen (primary objective).<br /><br>2. To examine the relation between the gestational age (weeks) and the<br /><br>pharmacokinetics of the antibiotic regimen (primary objective).<br /><br>3. To examine the relation between maternal age (years) and the<br /><br>pharmacokinetics of the antibiotic regimen (primary objective).<br /><br>4. To examine the relation between fetal sex and the pharmacokinetics of the<br /><br>antibiotic regimen (primary objective).<br /><br>5. To examine the relation between maternal SNPs in cytochrome P450 isoenzyme<br /><br>genes and the pharmacokinetics of the antibiotic regimen (primary objective).</p><br>