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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 level

Fetal 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

Page last updated: August 23, 2015

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