Clinical trial NCT02792556: Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
Official title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Abortion
Keywords: drug abortion
urine pregnancy test
negative predictive value
check Top test
transvaginal ultrasound
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake.

Brief summary: According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.

The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.

The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.

In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.

To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.

The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.

This is a monocentric observational study.


Eligibility criteria: * Inclusion Criteria:

  * Women ≥18 years of age
  * Undergoing drug abortion in Orthogenic Departement, Croix-Rousse Hospital, Lyon
  * Intrauterine pregnancy, single or multiple, until 8 weeks of amenorrhea
  * Agreeing to participate in the study after receiving information note
  * Affiliated to a social security system
  * Not subject to a measure of legal protection
* Exclusion Criteria:

  * Women \<18 years
  * Ineligible patient to drug abortion
  * Patient practicing a surgical abortion

Primary outcomes:
measure: Negative predictive value of urine pregnancy test CHECK TOP
timeFrame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Secondary outcomes:
measure: Positive predictive value of urine pregnancy test Check Top
timeFrame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
measure: Sensibility of urine pregnancy test Check Top
timeFrame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
measure: Specificity of urine pregnancy test Check Top
timeFrame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
measure: Acceptability of urine pregnancy test Check Top by patients.
timeFrame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
Study officials:
References: