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 range

16 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Pregnancy Related trials

Who can participate

Age range

16 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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