Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250884
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Pregnancy Related Diagnostic Emergencies Pelvic Pain Metrorrhagia

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Waiting time in emergency unit for patients [ Time Frame: 6 months ]
    Waiting time in emergency unit for patients

  2. Amount of blood tests avoided with the rapid pregnancy diagnostic test [ Time Frame: 6 months ]
    Amount of blood tests avoided with the rapid pregnancy diagnostic test


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy test
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250884


Locations
Layout table for location information
France
Rennes university hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Vincent Lavoué, Pr Rennes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03250884    
Other Study ID Numbers: 35RC16_3038
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metrorrhagia
Emergencies
Pelvic Pain
Disease Attributes
Pathologic Processes
 Pain
Neurologic Manifestations
Uterine Hemorrhage
Uterine Diseases
Hemorrhage