Cefazolin for Twin pregnancy | Pregnancy

Inclusion criteria

• {"criterion_text":"- Women with twin pregnancies and delivery through c-section between 24- 42 gestational weeks\n- Receiving one or more of the included antibiotic agents\n- Able and willing to sign the consent\n- Ages 18-55 years old"}

Exclusion criteria

• {"criterion_text":"- Any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives\n- Patients who are not willing to sign the consent"}

Primary endpoints

• {"endpoint_text":"- Pharmacokinetic: Differences in antibiotic concentration between twin pairs","definition_or_measurement_approach":"Determine the antibiotic concentration in maternal blood and newborn blood (from the umbilical cord) to assess differences in antibiotic concentration between twin siblings."}
• {"endpoint_text":"- Antibiotic cord/maternal ratio","definition_or_measurement_approach":"Ratio of antibiotic concentration measured in umbilical cord blood to maternal blood concentrations."}
• {"endpoint_text":"- The maternal antibiotic volume of distribution (Vd)","definition_or_measurement_approach":"Estimation of maternal pharmacokinetic parameter: volume of distribution (Vd) based on measured antibiotic concentrations."}
• {"endpoint_text":"- clearance (Cl)","definition_or_measurement_approach":"Estimation of maternal pharmacokinetic parameter: clearance (Cl) based on measured antibiotic concentrations."}
• {"endpoint_text":"- Protein binding (PB)","definition_or_measurement_approach":"Assessment of protein binding of the antibiotic as indicated by pharmacokinetic analyses."}
• {"endpoint_text":"- Placenta interstitial fluid concentration","definition_or_measurement_approach":"Measurement of antibiotic concentration in placental interstitial fluid (as specified in primary endpoint list)."}
• {"endpoint_text":"- Umbilical cord antibiotic concentration","definition_or_measurement_approach":"Measurement of antibiotic concentration in umbilical cord (newborn) blood."}

Secondary endpoints

• {"endpoint_text":"- Clinical descriptive endpoints: Maternal postoperative infection or sepsis, Early-onset neonatal sepsis.","definition_or_measurement_approach":"Descriptive clinical assessment/recording of occurrences of maternal postoperative infection or sepsis and early-onset neonatal sepsis."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Collection of reported adverse drug reactions (clinically observed, haematological, or biochemical) as reported by clinical staff and suspected to be related to study antibiotics."}
• {"endpoint_text":"- Substudy endpoints: Differences in antibiotic concentration between monochorionic and dichorionic twin pairs","definition_or_measurement_approach":"Comparison of measured antibiotic concentrations between monochorionic and dichorionic twin pairs."}

Austria

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

36

Number Of Sites

1

Number Of Participants

92

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria