Acetaminophen and the Assessment of Fetal Well-being

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01211912
First received: September 28, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

This study aims to understand the impact of maternal acetaminophen use on fetal movement and breathing.


Condition Intervention Phase
Fetal Testing
Drug: Acetaminophen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Acetaminophen and the Assessment of Fetal Well-being

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maternal serum acetaminophen level [ Time Frame: 30-120 minutes post administration ] [ Designated as safety issue: No ]
    Pregnant women will be given 1000 mg of acetaminophen orally and have serum acetaminophen levels checked 30-120 minutes after administration.

  • Neonatal serum acetaminophen level [ Time Frame: 30-120 minutes post administration ] [ Designated as safety issue: No ]
    Pregnant women will be given 1000 mg of acetaminophen orally and their newborns will have serum acetaminophen levels checked 30-120 minutes after administration.

  • Fetal body movements [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Pregnant women will have a baseline assessment of fetal body movement assessed by ultrasound and then given 1000 mg of acetaminophen orally. Fetal body movement will then reassessed 60 minutes later.

  • Fetal breathing [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Pregnant women will have a baseline assessment of fetal breathing with ultrasound and will then be given 1000 mg of acetaminophen orally. Fetal breathing will then be reassessed 60 minutes later.


Enrollment: 56
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetaminophen
Pregnant women will be given a single dose of 1000 mg of acetaminophen orally before a scheduled cesarian section.
Drug: Acetaminophen
Acetaminophen 1000 mg by mouth once
Other Name: Tylenol

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211912

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: William Watson, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: William Watson, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01211912     History of Changes
Other Study ID Numbers: 10-003283
Study First Received: September 28, 2010
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Fetal movement
Fetal breathing
Acetaminophen

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014