Pregnancy
Conditions
Brief summary
Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration
Detailed description
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, haematological 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
Interventions
DRUGStandacillin 2 g – Pulver zur Herstellung einer Injektions-/Infusionslösung
DRUGDalacin C® Phosphat 600 mg/4 ml – Ampulle
DRUGPiperacillin/Tazobactam Sandoz 4
DRUG0 g/0
DRUG5 g - Pulver zur Herstellung einer Infusionslösung
Sponsors
Medical University Of Vienna
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic: Differences in antibiotic concentration between twin pairs, Antibiotic cord/maternal ratio, The maternal antibiotic volume of distribution (Vd), clearance (Cl), Protein binding (PB), Placenta interstitial fluid concentration, Umbilical cord antibiotic concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, haematological 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 | — |
Countries
Austria
Outcome results
None listed