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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Fetal Testing; Transplacental Transfer of Acetaminophen

Treatments: Drug: Arm 2 (34 patients); Drug: Arm 1 (20 patients)

Study type: Interventional

Funder types: Other

Identifiers

NCT01211912

10-003283

Details and patient eligibility

About

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)

Enrollment: 56 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Arm 1 (20 patients)

Experimental group

Description:

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.

Treatment:

Drug: Arm 1 (20 patients)

Arm 2 (34 patients)

Experimental group

Description:

Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section.

Treatment:

Drug: Arm 2 (34 patients)