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Completed

NCT Number: NCT01211912

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

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)

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Key information

Conditions

Fetal Testing Transplacental Transfer of Acetaminophen

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1 (20 patients)

Drug

Acetaminophen 1000 mg by mouth once

Other names: Tylenol

Arm 2 (34 patients)

Drug

Acetaminophen 1000 mg by mouth once

Other names: Tylenol

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.