Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

Rennes University Hospital

Status: Completed

Conditions: Metrorrhagia; Emergencies; Diagnostic; Pelvic Pain; Pregnancy Related

Study type: Observational

Funder types: Other

Identifiers

NCT03250884

35RC16_3038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.