Medical AbortionNCT03014193
Simplifying First Trimester Medical Abortion Follow-up
An observational study of Medical Abortion, run by Gynuity Health Projects at 5 sites in 3 countries.
Trial summary
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Semiquantitative Multi-Level Pregnancy Test
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2017to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women seeking medical abortion with pregnancies of 63 days or less.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Armenia2 sites
Gyumri Maternity Hospital
Gyumri
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Yerevan
About this study
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.
- Conditions
- Medical Abortion
- Being tested
- Semiquantitative Multi-Level Pregnancy Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiquantitative Multi-Level Pregnancy TestDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of the instructions for the multilevel pregnancy test
Measured: 14 days
Ability to independently use the multilevel pregnancy tests
Measured: 14 days
Ability to interpret the results of the multilevel pregnancy test
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014193
- Sponsor's protocol ID
- 6009
- Status last verified
- Nov 2017
- First submitted
- 5 Jan 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying First Trimester Medical Abortion Follow-up
- ClinicalTrials.gov ID
- NCT03014193
- Acronym / sponsor ID
- 6009
- Conditions
- Medical Abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women seeking medical abortion with pregnancies of 63 days or less.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiquantitative Multi-Level Pregnancy Test | Device | – |
Primary outcome
Understanding of the instructions for the multilevel pregnancy test
Time frame: 14 days
Ability to independently use the multilevel pregnancy tests
Time frame: 14 days
Ability to interpret the results of the multilevel pregnancy test
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Related trials for Medical Abortion
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruiting
'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial
Medical Abortion
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Abortion, run by Gynuity Health Projects at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Armenia, Georgia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of the instructions for the multilevel pregnancy test (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.