NCT03014193

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

January 5, 2017

Last Update Submit

November 1, 2017

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (3)

  • Understanding of the instructions for the multilevel pregnancy test

    14 days

  • Ability to independently use the multilevel pregnancy tests

    14 days

  • Ability to interpret the results of the multilevel pregnancy test

    14 days

Interventions

Semiquantitative Multi-Level Pregnancy TestDEVICE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women seeking medical abortion with pregnancies of 63 days or less.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gyumri Maternity Hospital

Gyumri, Armenia

Location

Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology

Yerevan, Armenia

Location

Batumi International Hospital

Batumi, Georgia

Location

David Gagua Clinic

Tbilisi, Georgia

Location

City Policlinic #17

Almaty, Kazakhstan

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

GE(2)KA(1)AR(2)