Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).

Civil Hospices of Lyon

Status: Unknown

Conditions: Drug Abortion

Treatments: Device: Urine pregnancy test

Study type: Observational

Funder types: Other

Identifiers

NCT02792556

69HCL16_0263

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 1 patient group

patient having a drug abortion

Description:

Urine pregnancy test for 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.

Treatment:

Device: Urine pregnancy test