CompletedPhase 1

Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

United States13 participantsStarted 2023-08-29

Plain-language 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.

Who can participate

Age range16 Years – 50 Years

SexFEMALE

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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).

What they're measuring

Change of Amoxicillin Level in Plasma during Pregnancy

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

Amoxicillin Level in Cord Blood

Timeframe: at delivery

Change of Amoxicillin Level in Plasma in the Postpartum state

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

Trial details

NCT IDNCT05309928

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-16

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