Status:

COMPLETED

Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

Lead Sponsor:

Rennes University Hospital

Conditions:

Pregnancy Related

Diagnostic

Eligibility:

FEMALE

18-60 years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 30 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2017

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03250884

Start Date

August 30 2016

End Date

December 1 2017

Last Update

April 17 2018

Active Locations (1)

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Rennes university hospital

Rennes, France, 35033