The target population are twin pregnancy women that will deliver through c-section and that are receiving one or more of the included antibiotics.
Conditions
Interventions
Trade Name: Kefzol
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 25953-19-9
Other descriptive name: Cefazolin sodium
Concentration unit: g gram(s)
Concentration type: equal
Concent
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women with twin pregnancy and delivery through c-section between 24-42 gestational weeks - Receiving one or more of the included antibiotic agents - Ages 18-55 years old - Able and willing to sign the consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives. - Patients who are not willing to sign the consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Determine the antibiotic concentration in maternal blood and newborn blood (from umbilical cord) and investigate potential difference in antibiotic concentration between twin siblings. ;Secondary Objective: -Determine whether antibiotic dosing for pregnant patients achieves the concentrations associated with sufficient probability of target attainment - Determine the antibiotic concentration in maternal placenta -Safety and tolerability of the included antibiotics ;Primary end point(s): Pharmacokinetic endpoints: -Differences in antibiotic concentration between twin pairs (coefficient of variation) Antibiotic cord/maternal ratio (Twin/maternal concentrations) -Maternal antibiotic volume of distribution (Vd), clearance (Cl) -Protein binding (PB). -Umbilical cord antibiotic concentration. - Placenta antibiotic concentration ;Timepoint(s) of evaluation of this end point: End of study day and final examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical descriptive endpoints: - Maternal postoperative infection or sepsis. - Early-onset neonatal sepsis. Safety endpoints: Safety and tolerability of the antibiotics will be collected to define any adverse drug reaction (clinically observed, hematological or biochemical) that is reported by the clinical staff that is suspected as being caused by any of the study antibiotics. Substudy endpoints: Differences in antibiotic concentration between monochorionic and dichorionic twin pairs.;Timepoint(s) of evaluation of this end point: End of study day and final examination | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University Vienna
Outcome results
None listed