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

Phase 1

Completed

• Conditions: Fetal Testing; Transplacental Transfer of Acetaminophen
• Interventions: Drug: Arm 2 (34 patients); Drug: Arm 1 (20 patients)

• Registration Number: NCT01211912
• Lead Sponsor: Mayo Clinic

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2 (34 patients)	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.
Arm 1 (20 patients)	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.

Primary Outcome Measures

Name	Time	Method
Maternal and neonatal serum acetaminophen level	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: 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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States