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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211912
First Posted: September 30, 2010
Last Update Posted: September 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian C. Brost, M.D., Mayo Clinic
  Purpose

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)

Condition Intervention Phase
Fetal Testing Transplacental Transfer of Acetaminophen Drug: Arm 1 (20 patients) Drug: Arm 2 (34 patients) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being

Resource links provided by NLM:


Further study details as provided by Brian C. Brost, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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.

  • 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.


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: 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 Name: 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 Name: Tylenol

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211912


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

Responsible Party: Brian C. Brost, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01211912     History of Changes
Other Study ID Numbers: 10-003283
First Submitted: September 28, 2010
First Posted: September 30, 2010
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Brian C. Brost, M.D., Mayo Clinic:
Fetal movement
Fetal breathing
Acetaminophen

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