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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014