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

NCT ID: NCT02792556

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Abortion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patient having a drug abortion

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.

Urine pregnancy test

Intervention Type DEVICE

Urine pregnancy test Check Top after transvaginal ultrasound

Interventions

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Urine pregnancy test

Urine pregnancy test Check Top after transvaginal ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corine REBELLE, MD

Role: CONTACT

+33 4 72 07 16 63

Mahé RAFFIN

Role: CONTACT

+33 4.26.73.27.38

Facility Contacts

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Corinne REBELLE

Role: primary

+33 4 72 07 16 63

Other Identifiers

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69HCL16_0263

Identifier Type: -

Identifier Source: org_study_id

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