Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

Pregnancy Related Clinical Trial

Official title:

Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250884
• Other study ID #: 35RC16_3038
• Status: Completed
• First received: August 11, 2017
• Last updated: April 13, 2018
• Start date: August 30, 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 ß-human chorionic gonadotropin blood test.

Exclusion Criteria:

• Previous pregnancy diagnostic assessed using the ß-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.

Related Conditions & MeSH terms

• Diagnostic
• Emergencies
• Metrorrhagia
• Pelvic Pain
• Pregnancy Related

Locations

Country	Name	City	State
France	Rennes university hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ß-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 ß-human chorionic gonadotropin concentration.	6 months
Secondary	Waiting time in emergency unit for patients	Waiting time in emergency unit for patients	6 months
Secondary	Amount of blood tests avoided with the rapid pregnancy diagnostic test	Amount of blood tests avoided with the rapid pregnancy diagnostic test	6 months