Fetal TestingPhase 1NCT01211912
Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
A Phase 1 study testing Arm 1 (20 patients) and Arm 2 (34 patients) in people with Fetal Testing and Transplacental Transfer of Acetaminophen, run by Mayo Clinic at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Testing, Transplacental Transfer of Acetaminophen
- What is being tested?
- Arm 1 (20 patients) and Arm 2 (34 patients)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant females
- Age 18-44
- Any race
- Any parity
- Singleton Gestations
- Weight between 60-90 kg
Who cannot join
- Acetaminophen Allergy
- Contraindication to Acetaminophen Use
- Chorioamnionitis
- Preeclampsia
- Diabetes Mellitus
- Placental Abruption
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study has two aims:
- to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)
- to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)
- Being tested
- Arm 1 (20 patients), Arm 2 (34 patients)
- Keywords
- Fetal movement, Fetal breathing, Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 (20 patients)Drug
Also called Tylenol
Acetaminophen 1000 mg by mouth once
Arm 2 (34 patients)Drug
Also called Tylenol
Acetaminophen 1000 mg by mouth once
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (20 patients) | Experimental | 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. Receives: Drug: Arm 1 (20 patients) |
| Arm 2 (34 patients) | Experimental | Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section. Receives: Drug: Arm 2 (34 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and neonatal serum acetaminophen level
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.
Measured: Time Frame: 30 minutes to 24 hours post administration
Fetal breathing and body movements
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.
Measured: Time Frame: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal TestingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian C. Brost, M.D., Mayo Clinic
- Investigators
- Brian C Brost, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211912
- Sponsor's protocol ID
- 10-003283
- Status last verified
- Aug 2014
- First submitted
- 28 Sep 2010
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
- ClinicalTrials.gov ID
- NCT01211912
- Acronym / sponsor ID
- 10-003283
- Keywords
- Fetal movement, Fetal breathing, Acetaminophen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two aims:
- to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)
- to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (20 patients) | Experimental | Drug: 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. |
| Arm 2 (34 patients) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant females
- Age 18-44
- Any race
- Any parity
- Singleton Gestations
Key exclusion criteria (13 listed)
- Acetaminophen Allergy
- Contraindication to Acetaminophen Use
- Chorioamnionitis
- Preeclampsia
- Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 (20 patients)Also: TylenolAcetaminophen 1000 mg by mouth once | Drug | Arm 1 (20 patients) |
| Arm 2 (34 patients)Also: TylenolAcetaminophen 1000 mg by mouth once | Drug | Arm 2 (34 patients) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Brost, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arm 1 (20 patients) and Arm 2 (34 patients) in people with Fetal Testing and Transplacental Transfer of Acetaminophen, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and neonatal serum acetaminophen level (time frame: Time Frame: 30 minutes to 24 hours post administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.