Fetal Testing, Transplacental Transfer of Acetaminophen
Conditions
Keywords
Fetal movement, Fetal breathing, Acetaminophen
Brief summary
This study has two aims: 1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients) 2. to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)
Interventions
DRUGArm 1 (20 patients)
Acetaminophen 1000 mg by mouth once
DRUGArm 2 (34 patients)
Acetaminophen 1000 mg by mouth once
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant females * Age 18-44 * Any race * Any parity * Singleton Gestations * Weight between 60-90 kg
Exclusion criteria
* Acetaminophen Allergy * Contraindication to Acetaminophen Use * Chorioamnionitis * Preeclampsia * Diabetes Mellitus * Placental Abruption * Placenta Previa * Fetal Anomaly * Intrauterine growth restriction (IUGR) * Multiple Gestations * Maternal Medical Disease * Acetaminophen use in the last 3 days * Plan to donate or bank fetal cord blood
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal and neonatal serum acetaminophen level | Time Frame: 30 minutes to 24 hours post administration | Pregnant women will be given 1000 mg of acetaminophen orally and have both maternal and neonatal serum acetaminophen levels checked at the time of cesarean section 30 minutes to 24 hours after administration. |
| Fetal breathing and body movements | Time Frame: 60 minutes | Pregnant women will have a baseline assessment of fetal breathing and body movements with ultrasound and will then be given 1000 mg of acetaminophen orally. Fetal breathing and body movements will then be reassessed 60 minutes later. |
Countries
United States
Outcome results
None listed