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This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women undergoing maternal-fetal surgery | Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of fetal anesthesia | Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development. | 2 years |
| Area under the plasma concentration versus time curve (AUC) of fetal anesthesia | Characterize the plasma concentrations / pharmacokinetics profile, specifically the area under the plasma concentration versus time curve (AUC) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal blood concentration of fetal anesthesia | Measure the maternal blood concentration of fetal anesthesia to characterize fetal-maternal transfer of commonly used fetal anesthetics. | 2 years |
| Fetal blood concentration of maternal anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women undergoing maternal-fetal surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Atayde, BS | Contact | 617-355-2967 | julia.atayde@childrens.harvard.edu | |
| Rachel Bernier, BS, MPH | Contact | 857-218-5348 | rachel.bernier@childrens.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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Retained samples will consist of small-volume discarded fetal blood specimens (approximately 100-250 µL per sample) collected during clinically indicated fetal procedures that would otherwise be discarded. For participants who separately consent to the optional component, retained samples may also include maternal peripheral blood specimens collected at time points matched to fetal sampling.
Measure the fetal blood concentration of maternal anesthesia to characterize fetal-maternal transfer of commonly used maternal anesthetics.
| 2 years |