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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian C. Brost, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01211912
First received: September 28, 2010
Last updated: August 29, 2014
Last verified: August 2014
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 Mayo Clinic:

Primary Outcome Measures:
  • Maternal and neonatal serum acetaminophen level [ Time Frame: Time Frame: 30 minutes to 24 hours post administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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: Brian C Brost, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Brian C. Brost, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01211912     History of Changes
Other Study ID Numbers: 10-003283
Study First Received: September 28, 2010
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 16, 2014