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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 20231 |
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This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
There is very little data on drug metabolism during pregnancy, and how it may differ from the non-pregnant woman. There is even less data on placental transfer of drug to the neonate when medications are given prior to delivery. This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
The investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the profile of neonatal metabolism of the drug that crosses the placental barrier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron/Cefazolin treatment | Pregnant women undergoing uncomplicated cesarean section deliveries who have consented to participate, and will receive Ondansetron and Cefazolin in the course of their clinical care will have PK blood samples drawn. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebotomy | Procedure | Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens | Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute. | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of placental transfer of studied meds (Cefazolin and Ondansetron) | By measuring the PK of the studied drugs in the umbilical cord sample we hope to gain information regarding placental transfer. Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute. |
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Inclusion Criteria:
Adult participant:
Neonatal participant:
Exclusion Criteria:
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Generally health women at 37-42 weeks gestation, and their newborns.
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Carvalho | Stanford University | Sub-Investigator |
| David R. Drover | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Blood samples for pharmacokinetics.
| 1 hr |
| PK results of neonatal blood specimens | Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute. | 48 h |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |