Acetaminophen and the Assessment of Fetal Well-being
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01211912
First received: September 28, 2010
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
This study aims to understand the impact of maternal acetaminophen use on fetal movement and breathing.
| Condition | Intervention |
|---|---|
|
Fetal Testing |
Drug: Acetaminophen |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Acetaminophen and the Assessment of Fetal Well-being |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Maternal serum acetaminophen level [ Time Frame: 30-120 minutes post administration ] [ Designated as safety issue: No ]Pregnant women will be given 1000 mg of acetaminophen orally and have serum aceteminophen levels checked 30-120 minutes after administration.
- Neonatal serum acetaminophen level [ Time Frame: 30-120 minutes post administration ] [ Designated as safety issue: No ]Pregnant women will be given 1000 mg of acetaminophen orally and their newborns will have serum acetaminophen levels checked 30-120 minutes after administraiton.
- Fetal body movements [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]Pregnant women will have a beseline assessment of fetal body movement assessed by ultrasound and then given 1000 mg of acetaminophen orally. Fetal body movement will then reassessed 60 minutes later.
- Fetal breathing [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]Pregnant women will have a baseline assessment of fetal breathing with ultrasound and will then be given 1000 mg of acetaminophen orally. Fetal breathing 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: Acetaminophen
Pregnant women will be given a single dose of 1000 mg of acetaminophen orally before a scheduled cesarian section.
|
Drug: Acetaminophen
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 More Information
No publications provided
| Responsible Party: | William Watson, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01211912 History of Changes |
| Other Study ID Numbers: | 10-003283 |
| Study First Received: | September 28, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Fetal movement Fetal breathing Acetaminophen |
Additional relevant MeSH terms:
|
Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013