Gestational AgeNCT01816737
Fetal Blood Flow Response to Partial Occlusion by External Compression
An observational study of Gestational Age, run by Meir Medical Center.
Trial summary
Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2013
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women
Who may be able to join
- singleton
Who cannot join
- multiple gestation
About this study
Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.
- Conditions
- Gestational Age
What is being measured
The primary outcome is the main question the study is designed to answer.
pulsatility index in fetal vessels
Measured: at the time of pressure aplication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational AgeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816737
- Sponsor's protocol ID
- MMC13191-12CTIL
- Other IDs
- 0191-12-MMC
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Blood Flow Response to Partial Occlusion by External Compression
- ClinicalTrials.gov ID
- NCT01816737
- Acronym / sponsor ID
- MMC13191-12CTIL
- Conditions
- Gestational Age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (estimated)
- First posted
- 22 Mar 2013 (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.
Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (1 listed)
- singleton
Key exclusion criteria (1 listed)
- multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pulsatility index in fetal vessels
Time frame: at the time of pressure aplication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age, run by Meir Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
pulsatility index in fetal vessels (time frame: at the time of pressure aplication). 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 22 Mar 2013.