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Completed

NCT Number: NCT05309928

Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

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.

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Key information

Conditions

Pregnancy Related

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

UAB

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant, engaged in prenatal care with a medical provider (at least one visit)
  • Estimated gestational age 24-34 weeks
  • Able to provide informed consent
  • English speaking

Exclusion criteria

  • 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).
  • Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics.
  • Known renal impairment (serum creatinine ≥1.2 mg/dL).
  • 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).

Treatment and study plan

Amoxicillin

Drug

medication administration

Other names: Probenecid

Primary outcomes

  1. Change of Amoxicillin Level in Plasma during Pregnancy

    Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration

    quantitative drug level in blood

  2. Amoxicillin Level in Cord Blood

    Time frame: at delivery

    quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin

  3. Change of Amoxicillin Level in Plasma in the Postpartum state

    Time frame: 0, 1, 2, 3, 4, 6, 8 hours after medication administration

    quantitative drug levels in blood to compare to pregnancy state values

Secondary outcomes

  1. additional pharmacologic measures

    Time frame: 1-8 hours after administration

    • Maximum concentration (Cmax) in maternal serum.

  2. Additional pharmacologic measure

    Time frame: 1-8 hours after administration

    time to maximum concentration (tmax) in maternal serum

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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