Pregnancy Related
Conditions
Keywords
pharmacokinetics, amoxicillin
Brief summary
The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.
Detailed description
Twenty adult pregnant women in good health who are admitted for preterm premature rupture of membranes (24-34 weeks gestational age) will be enrolled in this intensive pharmacokinetic study. Basic information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.
Interventions
DRUGAmoxicillin
medication administration
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant, engaged in prenatal care with a medical provider (at least one visit) 2. Estimated gestational age 24-34 weeks 3. Able to provide informed consent 4. English speaking
Exclusion criteria
1. Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean with cephalexin and azithromycin 500 mg IV is allowed). 2. Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics. 3. Known renal impairment (serum creatinine ≥1.2 mg/dL). 4. Active concomitant medications known to interact with amoxicillin: allopurinol, methotrexate, mycophenolate, immune checkpoint inhibitors (ie. pembrolizumab), tetracyclines (ie. doxycycline), vitamin K antagonists (ie. warfarin), aminoglycosides (ie. gentamicin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Amoxicillin Level in Plasma during Pregnancy | 0, 1, 2, 3, 4, 6, 8 hours after medication administration | quantitative drug level in blood |
| Amoxicillin Level in Cord Blood | at delivery | quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin |
| Change of Amoxicillin Level in Plasma in the Postpartum state | 0, 1, 2, 3, 4, 6, 8 hours after medication administration | quantitative drug levels in blood to compare to pregnancy state values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| additional pharmacologic measures | 1-8 hours after administration | 1\. Maximum concentration (Cmax) in maternal serum. |
| Additional pharmacologic measure | 1-8 hours after administration | time to maximum concentration (tmax) in maternal serum |
Countries
United States
Outcome results
None listed