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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
medication administration
UAB
Birmingham, Alabama, United States
Change of Amoxicillin Level in Plasma during Pregnancy
quantitative drug level in blood
Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
Amoxicillin Level in Cord Blood
quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin
Time frame: at delivery
Change of Amoxicillin Level in Plasma in the Postpartum state
quantitative drug levels in blood to compare to pregnancy state values
Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
additional pharmacologic measures
1\. Maximum concentration (Cmax) in maternal serum.
Time frame: 1-8 hours after administration
Additional pharmacologic measure
time to maximum concentration (tmax) in maternal serum
Time frame: 1-8 hours after administration
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