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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amox 500 mg | Experimental | Amoxicillin 500 mg PO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | medication administration |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Amoxicillin Level in Plasma during Pregnancy | quantitative drug level in blood | 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 | at delivery |
| Change of Amoxicillin Level in Plasma in the Postpartum state | quantitative drug levels in blood to compare to pregnancy state values | 0, 1, 2, 3, 4, 6, 8 hours after medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| additional pharmacologic measures | 1. Maximum concentration (Cmax) in maternal serum. | 1-8 hours after administration |
| Additional pharmacologic measure | time to maximum concentration (tmax) in maternal serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jodie Dionne, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35294 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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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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| 1-8 hours after administration |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D013450 | Sulfones |