CompletedNCT03250884Updated Apr 17, 2018

Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

An observational study in Pregnancy Related, Diagnostic and Emergencies, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-17.

Primary conditionPelvic PainRegistry: DiseaseReclassifiedWhy we changed it

Registry

Disease — the first condition term the registry derived for this study.

ClinicalTrials.gg

Pelvic Pain

Why

Disease describes something many studies share rather than a condition a study is about.
The study's listed conditions name Pelvic Pain.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Rennes University Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years to 60 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Pregnancy Related
Diagnostic
Emergencies
Pelvic Pain
Metrorrhagia

Browse trials for

Disease 2,423Registry's first term
Emergencies 1,328
Pelvic Pain 375Primary · reclassified
Metrorrhagia 153

In context

Pelvic Pain Reclassified

375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 83 observational studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Browse Rennes University Hospital studies →

Compared within Pelvic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 200 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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.
Time frame: 6 months

Secondary outcomes

Waiting time in emergency unit for patients
Waiting time in emergency unit for patients
Time frame: 6 months
Amount of blood tests avoided with the rapid pregnancy diagnostic test
Amount of blood tests avoided with the rapid pregnancy diagnostic test
Time frame: 6 months

Study locations

1 site

Rennes university hospital
Rennes, 35033, France

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Dec 2017, 16 months.

Of 33 observational studies under Pelvic Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15. This study's 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 11, 2017
First posted: Aug 16, 2017
StartActual: Aug 30, 2016
Primary completionActual: Dec 2017
CompletionActual: Dec 2017
Last update: Apr 17, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03250884
Lead sponsor: Rennes University Hospital
Responsible party: Sponsor
First posted: Aug 16, 2017
Start date: Aug 30, 2016
Primary completion: Dec 2017
Completion: Dec 2017
Last update: Apr 17, 2018

Study contacts

Vincent Lavoué, Pr

principal investigator · Rennes University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pelvic Pain →

Other studies from this sponsor

Rennes University Hospital →

Start the discussion