Drug Abortion
Conditions
Keywords
drug abortion, urine pregnancy test, negative predictive value, check Top test, transvaginal ultrasound
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.
Interventions
DEVICEUrine pregnancy test
Urine pregnancy test Check Top after transvaginal ultrasound
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value of urine pregnancy test CHECK TOP | During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) | Negative predictive value of urine pregnancy test CHECK TOP taking as reference transvaginal ultrasound. A negative result at transvaginal ultrasound will be defined as the absence of ongoing pregnancy. An ongoing pregnancy is characterized by the presence of gestational sac, yolk sac and/or embryo with cardiac activity. A positive result will be retained only in case of ongoing pregnancy. Check Top test will be considered as negative if only one colored line appears in the control window, without any line in the result window. It will be considered as positive if two colored lines are present in the result window, corresponding to a β-HCG level \> 1000 IU/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of urine pregnancy test Check Top by patients. | During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) | Questionnaire |
| Positive predictive value of urine pregnancy test Check Top | During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) | Positive predictive value of urine pregnancy test Check Top compared to transvaginal ultrasound. |
| Sensibility of urine pregnancy test Check Top | During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) | Sensibility of urine pregnancy test Check Top compared to transvaginal ultrasound. |
| Specificity of urine pregnancy test Check Top | During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) | Specificity of urine pregnancy test Check Top compared to transvaginal ultrasound. |
Countries
France
Contacts
Primary ContactCorine REBELLE, MD
Backup ContactMahé RAFFIN
Outcome results
None listed