Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion

NCT02304835 | Completed

• 1 other identifier: BETINA
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres. The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.

Conditions

Abortion; Attempted, Medical

Outcome Measures

Primary Outcomes (1)

• concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.

  There was concordance if : * The result of urinary test is \< 1000 IU/L and the value of β-hCG blood measurement was \< 1000 IU/L, Or if * The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L. There was discrepancy if: * The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was \< 1000 IU/L, Or if * The result of urinary test is \< 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.

  At the follow-up at 2-3 weeks after inclusion

Secondary Outcomes (1)

• Acceptability of the urinary semi-quantitative test by the patient

  at the follow up at 2-3 weeks after the inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women asking for medical abortion

You may qualify if:

• Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
• Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
• Informed patients accepting the computer processing of their medical data and their right of access and correction.

You may not qualify if:

• Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
• Patients with contraindications to medical abortion.
• Patients with severe and progressive disease.
• Patients unable to complete a questionnaire.
• Patients refusing to participate in the study.

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Cabinet Médical

Paris, France

Location

Study Officials

• Danielle HASSOUN, MD

  Cabinet Médical

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 2, 2014
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

FR (1)