PregnancyNCT02640378
Semiquantitative Urine Pregnancy Test Results At ≥9 Weeks of Gestation
An observational study of Pregnancy, run by Gynuity Health Projects.
Trial summary
Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation. Read more about this study
- Who is it for?
- Ages 10 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jan 2015
- 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 10 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: pregnant women at >9 weeks gestation
Who may be able to join
- pregnant at >9 weeks of gestation
Who cannot join
- none
About this study
Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.
- Conditions
- Pregnancy
- Being tested
- NO intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventionOther
This study was a cross-sectional study. It had no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine HCG concentration
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640378
- Sponsor's protocol ID
- 1018
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semiquantitative Urine Pregnancy Test Results At ≥9 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT02640378
- Acronym / sponsor ID
- 1018
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Dec 2015 (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.
Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pregnant women at >9 weeks gestation
Key inclusion criteria (1 listed)
- pregnant at >9 weeks of gestation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NO interventionThis study was a cross-sectional study. It had no intervention. | Other | – |
Primary outcome
Urine HCG concentration
Time frame: 1 day
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 28 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Elizabeth Raymond study director
Gynuity Health Projects
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Gynuity Health Projects.
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: finished, as of the sponsor's last update on 28 Dec 2015. 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?
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?
Urine HCG concentration (time frame: 1 day). 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 28 Dec 2015.