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

August 29, 2014 updated by: Brian C. Brost, M.D., Mayo Clinic

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Arm 1 (20 patients)
Acetaminophen 1000 mg by mouth once
Other Names:
  • Tylenol
EXPERIMENTAL: 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.
Drug: Arm 2 (34 patients)
Acetaminophen 1000 mg by mouth once
Other Names:
  • Tylenol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Brian C Brost, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (ESTIMATE)

September 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-003283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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