Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
NCT ID: NCT01211912
Last Updated: 2014-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Arm 1 (20 patients)
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.
Arm 1 (20 patients)
Acetaminophen 1000 mg by mouth once
Arm 2 (34 patients)
Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section.
Arm 2 (34 patients)
Acetaminophen 1000 mg by mouth once
Interventions
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Arm 1 (20 patients)
Acetaminophen 1000 mg by mouth once
Arm 2 (34 patients)
Acetaminophen 1000 mg by mouth once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-44
* Any race
* Any parity
* Singleton Gestations
* Weight between 60-90 kg
Exclusion Criteria
* 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
18 Years
44 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brian C. Brost, M.D.
PI
Principal Investigators
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Brian C Brost, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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10-003283
Identifier Type: -
Identifier Source: org_study_id
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