Clinical trial NCT03250884: Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
Official title: Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Diagnostic
Emergencies
Pelvic Pain
Metrorrhagia
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: Waiting time in emergency unit for patients
timeFrame: 6 months
measure: Amount of blood tests avoided with the rapid pregnancy diagnostic test
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes university hospital
Study officials:
affiliation: Rennes University Hospital
name: Vincent Lavoué, Pr
role: PRINCIPAL_INVESTIGATOR
References: