Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| David Drover, MD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.
Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following timepoints:
Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is clinically appropriate for the purposes of this study.
Umbilical venous and arterial blood will also be drawn for sampling from the placenta after delivery, and cutting of the umbilical cord.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant/Ampicillin | pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus |
| |
| Non-pregnant/Ampicillin | non-pregnant participants who will receive Ampicillin for a qualifying hospital admission |
| |
| Pregnant and Non-pregnant/Ampicillin and Gentamicin | pregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission |
| |
| Non-Pregnant/Gentamicin | non-pregnant participants who will receive Gentamicin for a qualifying hospital admission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin | Drug | Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy | blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study | predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier | blood samples to be drawn at the above timepoint; data analysis of all specimens will begin approx. 12-15 months from start of study | At delivery/upon cutting of umbilical cord |
| PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women receiving ampicillin or gentamicin
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brendan Carvalho, MBBCh | Stanford University | Study Director |
| David Drover, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital | Palo Alto | California | 94304 | United States |
Not provided
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ampicillin and Gentamicin | Drug | Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis |
|
| Gentamicin | Drug | Prescribed to non-pregnant participants |
|
subject will be observed for adverse events related to drug administration |
| predose; while dosing; post dose |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |