Simplifying First Trimester Medical Abortion Follow-up

Medical Abortion Clinical Trial

Official title:

Simplifying First Trimester Medical Abortion Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014193
• Other study ID #: 6009
• Status: Completed
• Phase: N/A
• First received: January 5, 2017
• Last updated: November 1, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Device:
• Semiquantitative Multi-Level Pregnancy Test

Locations

Country	Name	City	State
Armenia	Gyumri Maternity Hospital	Gyumri
Armenia	Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology	Yerevan
Georgia	Batumi International Hospital	Batumi
Georgia	David Gagua Clinic	Tbilisi
Kazakhstan	City Policlinic #17	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Armenia,  Georgia,  Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding of the instructions for the multilevel pregnancy test		14 days
Primary	Ability to independently use the multilevel pregnancy tests		14 days
Primary	Ability to interpret the results of the multilevel pregnancy test		14 days