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Simplifying First Trimester Medical Abortion Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03014193
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.

Condition or disease Intervention/treatment
Medical Abortion Device: Semiquantitative Multi-Level Pregnancy Test

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Simplifying First Trimester Medical Abortion Follow-up
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017



Primary Outcome Measures :
  1. Understanding of the instructions for the multilevel pregnancy test [ Time Frame: 14 days ]
  2. Ability to independently use the multilevel pregnancy tests [ Time Frame: 14 days ]
  3. Ability to interpret the results of the multilevel pregnancy test [ Time Frame: 14 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women seeking medical abortion with pregnancies of 63 days or less.
Criteria

Inclusion Criteria:

  • Have a first trimester pregnancy with a gestational age of ≤63 days;
  • Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;
  • Be able to read and understand the local language or Russian;
  • Have access to a telephone;
  • Agree to follow all study procedures;
  • Have no contraindication to participation in the study, in the judgment of the site investigator or designee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014193


Locations
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Armenia
Gyumri Maternity Hospital
Gyumri, Armenia
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Yerevan, Armenia
Georgia
Batumi International Hospital
Batumi, Georgia
David Gagua Clinic
Tbilisi, Georgia
Kazakhstan
City Policlinic #17
Almaty, Kazakhstan
Sponsors and Collaborators
Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03014193     History of Changes
Other Study ID Numbers: 6009
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017