PregnancyNCT01735695
Performance Evaluation Study for a New Meconium Detection Test
An observational study of Pregnancy, run by Laniado Hospital at 1 site in Israel.
Trial summary
The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
- Pregnant.
- Intend to seek medical care during pregnancy.
Who cannot join
- Amniotic fluid samples are mixed with urine.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Laniado Hospital
Netanya
Birgita Weintrov, MD
Brigita Weintrov, MD
About this study
The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.
Read the detailed description
Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.
Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.
- Conditions
- Pregnancy
- Keywords
- Meconium, concentration, level
What is being measured
The primary outcome is the main question the study is designed to answer.
Meconium concentration in amniotic fluid
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laniado Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigita Wintrov, MD, Study director, Laniado Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735695
- Sponsor's protocol ID
- Laniado25112012
- Other IDs
- Laniado25122012-1
- Status last verified
- Apr 2013
- First submitted
- 25 Nov 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation Study for a New Meconium Detection Test
- ClinicalTrials.gov ID
- NCT01735695
- Acronym / sponsor ID
- Laniado25112012
- Conditions
- Pregnancy
- Keywords
- Meconium, concentration, level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laniado HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Nov 2012 (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.
The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.
Detailed description
Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.
Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (3 listed)
- Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
- Pregnant.
- Intend to seek medical care during pregnancy.
Key exclusion criteria (1 listed)
- Amniotic fluid samples are mixed with urine.
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
Meconium concentration in amniotic fluid
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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.
Brigita Wintrov, MD study director
Laniado Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Laniado Hospital at 1 site in Israel.
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 3 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 30 Apr 2013. 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 Israel. 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.
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?
Contact Brigita Weitrov, MD (972-50-8840757, morami12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meconium concentration in amniotic fluid (time frame: One year). 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 30 Apr 2013.