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

Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).

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.

Study Overview

• Status: Unknown
• Conditions: Drug Abortion
• Intervention / Treatment: Device: Urine pregnancy test

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Corine REBELLE, MD; Phone Number: +33 4 72 07 16 63; Email: corine.rebelle@chu-lyon.fr
• Study Contact Backup: Name: Mahé RAFFIN; Phone Number: +33 4.26.73.27.38; Email: mahe.raffin@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon - Hopital de la Croix Rousse
    • Contact: Corinne REBELLE; Phone Number: +33 4 72 07 16 63; Email: corine.rebelle@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Urine pregnancy test; Urine pregnancy test Check Top after transvaginal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative predictive value of urine pregnancy test CHECK TOP	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.	During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of urine pregnancy test Check Top	Positive predictive value of urine pregnancy test Check Top compared to transvaginal ultrasound.	During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Sensibility of urine pregnancy test Check Top	Sensibility of urine pregnancy test Check Top compared to transvaginal ultrasound.	During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Specificity of urine pregnancy test Check Top	Specificity of urine pregnancy test Check Top compared to transvaginal ultrasound.	During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Acceptability of urine pregnancy test Check Top by patients.	Questionnaire	During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: transvaginal ultrasound; drug abortion; urine pregnancy test; negative predictive value; check Top test
• Other Study ID Numbers: 69HCL16_0263