Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fetal Testing; Transplacental Transfer of Acetaminophen
Intervention: Arm 1 (20 patients) (Drug); Arm 2 (34 patients) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Brian C Brost, MD, Principal Investigator, Affiliation: Mayo Clinic
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)
Clinical Details
Official title: Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Maternal and neonatal serum acetaminophen levelFetal breathing and body movements
Eligibility
Minimum age: 18 Years.
Maximum age: 44 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Additional Information
Starting date: September 2010
Last updated: August 29, 2014
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