Informations générales (source: ClinicalTrials.gov)

NCT02792556 Statut inconnu
Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP). (CHECK-TOP)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
septembre 2016
septembre 2018
29 juin 2024
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.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hospices Civils de Lyon - Hôpital de la Croix Rousse - 69004 - Lyon - France Corinne REBELLE En recrutement Contact (sur clinicalTrials)

Critères

Femme
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

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- Women <18 years

- Ineligible patient to drug abortion

- Patient practicing a surgical abortion