Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

NCT03250884 | Completed

• 1 other identifier: 35RC16_3038
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Diagnostic; Emergencies; Pelvic Pain; Metrorrhagia

Outcome Measures

Primary Outcomes (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.

  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.

  6 months

Secondary Outcomes (2)

• Waiting time in emergency unit for patients

  6 months

• Amount of blood tests avoided with the rapid pregnancy diagnostic test

  6 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: pregnancy test
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes university hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Disease; Emergencies; Pelvic Pain; Metrorrhagia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Study Officials

• Vincent Lavoué, Pr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 16, 2017
• Study Start: August 30, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 17, 2018

Record last verified: 2017-08

Locations

FR (1)