PregnancyNCT01077583
Performance Evaluation Study for Clearblue Pregnancy Test
An observational study of Pregnancy, run by SPD Development Company Limited at 5 sites in United States.
Trial summary
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information. 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
- Pregnancy
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Jul 2011
- 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: Eligibility: Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.
Who may be able to join
- Provide written informed consent to participate in the study and agree to comply with study procedures.
- Has menstrual bleeds.
- Seeking to become pregnant.
- Intend to seek medical care during pregnancy.
Who cannot join
- Has positive pregnancy test on screening.
- Has received medical treatment for infertility or is participating in an assisted fertility program.
- Known condition to contra-indicate pregnancy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Radiant Research Inc
Atlanta, Georgia, 30342-1524
Radiant Research, Inc.
Chicago, Illinois, 60654
Radiant Research Inc
Dallas, Texas, 75321
Radiant Research Inc
Edina, Minnesota, 55435
Radiant Research Inc
San Antonio, Texas, 78229
About this study
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.
Read the detailed description
Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.
Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.
- Conditions
- Pregnancy
- Keywords
- Pregnancy test, Wishing to become pregnant
What is being measured
The primary outcome is the main question the study is designed to answer.
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phyllis Marx, MD, Principal investigator, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077583
- Sponsor's protocol ID
- PROTOCOL-0148
- Status last verified
- Jan 2011
- First submitted
- 26 Feb 2010
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen J, Buchanan P, Johnson S, Godbert S, Zinaman M. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet. 2013 Dec;123(3):189-95. doi: 10.1016/j.ijgo.2013.05.028. Epub 2013 Sep 3.
PubMed 24079475
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation Study for Clearblue Pregnancy Test
- ClinicalTrials.gov ID
- NCT01077583
- Acronym / sponsor ID
- PROTOCOL-0148
- Conditions
- Pregnancy
- Keywords
- Pregnancy test, Wishing to become pregnant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Mar 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.
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.
Detailed description
Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.
Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eligibility: Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.
Key inclusion criteria (4 listed)
- Provide written informed consent to participate in the study and agree to comply with study procedures.
- Has menstrual bleeds.
- Seeking to become pregnant.
- Intend to seek medical care during pregnancy.
Key exclusion criteria (3 listed)
- Has positive pregnancy test on screening.
- Has received medical treatment for infertility or is participating in an assisted fertility program.
- Known condition to contra-indicate pregnancy.
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
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
Time frame: 1 year
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 Sep 2011.
- Derived from this study: PubMed 24079475Larsen J, Buchanan P, Johnson S, Godbert S, Zinaman M. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet. 2013 Dec;123(3):189-95. doi: 10.1016/j.ijgo.2013.05.028. Epub 2013 Sep 3.
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Phyllis Marx, MD principal investigator
Radiant Research
5 sites 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 SPD Development Company Limited at 5 sites 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 4 inclusion and 3 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 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077583, which also lists 1 linked publication.
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 Sep 2011.