Pregnancy RelatedNCT03250884
Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
An observational study of Pregnancy Related and Diagnostic, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy Related, Diagnostic, Emergencies
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2016to Dec 2017
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Adult women who come in emergency unit to consult for metrorrhagia and/or pelvic pains and who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Who may be able to join
- Adult women who are in genital activity
- Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.
- Lack of intrauterine gestational sac determined using endo-vaginal ultrasound
- Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Who cannot join
- Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test.
- Patients included in an ovarian stimulation program for infertility
- Ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound.
- Patient objecting to participate in the study
- Minor
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.
Read the detailed description
The most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. The gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. But this assay need time and expect women to wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration.
The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. A little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
- Conditions
- Pregnancy Related, Diagnostic, Emergencies, Pelvic Pain, Metrorrhagia
- Medical subject headings
- Disease, Emergencies, Pelvic Pain, Metrorrhagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
Measured: 6 months
Secondary outcomes (2)
Waiting time in emergency unit for patients
Waiting time in emergency unit for patients
Measured: 6 months
Amount of blood tests avoided with the rapid pregnancy diagnostic test
Amount of blood tests avoided with the rapid pregnancy diagnostic test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start30 Aug 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Lavoué, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250884
- Sponsor's protocol ID
- 35RC16_3038
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
- ClinicalTrials.gov ID
- NCT03250884
- Acronym / sponsor ID
- 35RC16_3038
- Conditions
- Pregnancy Related, Diagnostic, Emergencies, Pelvic Pain, Metrorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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 aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.
Detailed description
The most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. The gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. But this assay need time and expect women to wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration.
The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. A little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult women who come in emergency unit to consult for metrorrhagia and/or pelvic pains and who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Key inclusion criteria (4 listed)
- Adult women who are in genital activity
- Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.
- Lack of intrauterine gestational sac determined using endo-vaginal ultrasound
- Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Key exclusion criteria (6 listed)
- Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test.
- Patients included in an ovarian stimulation program for infertility
- Ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound.
- Patient objecting to participate in the study
- Minor
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
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
Time frame: 6 months
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.
2 secondary outcomes
Waiting time in emergency unit for patients
Time frame: 6 months
Amount of blood tests avoided with the rapid pregnancy diagnostic test
Time frame: 6 months
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 17 Apr 2018.
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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.
Vincent Lavoué, Pr principal investigator
Rennes University Hospital
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 Related and Diagnostic, run by Rennes University Hospital at 1 site in France.
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 6 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 17 Apr 2018. 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 France. 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?
Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration. (time frame: 6 months). 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 17 Apr 2018.