Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being

Study Overview
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Brief Summary
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This study has two aims: to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients) to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)

Official Title
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Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being

Conditions
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Fetal Testing, Transplacental Transfer of Acetaminophen

Intervention / Treatment
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* Drug: Arm 1 (20 patients)
* Drug: Arm 2 (34 patients)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (20 patients)<br>Pregnant women will be given a single dose of 1000 mg of acetaminophen orally after a baseline ultrasound and 60 minutes before a repeat ultrasound. | Drug: Arm 1 (20 patients)<br>* Acetaminophen 1000 mg by mouth once<br>* Other names: Tylenol;|
| Experimental: Arm 2 (34 patients)<br>Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section. | Drug: Arm 2 (34 patients)<br>* Acetaminophen 1000 mg by mouth once<br>* Other names: Tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and neonatal serum acetaminophen level | 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. | Time Frame: 30 minutes to 24 hours post administration | 
| Fetal breathing and body movements | 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. | Time Frame: 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal movement, Fetal breathing, Acetaminophen