Pregnancy RelatedNCT05459142
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.
An observational study of Pregnancy Related, run by Gynuity Health Projects at 1 site in Azerbaijan.
Trial summary
The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Medical Abortion
- How many people
- 50 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Jun 2022to 30 Nov 2022
- Phase
- Observational
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: Participants who seek early first-trimester abortion at the participating study site and would like to receive telemedicine medical abortion services.
Who may be able to join
- Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
- Has no contraindications to medical abortion
- Has access to a phone
- Is able to take mifepristone on or before 63 days of gestation
Who cannot join
- Medically ineligible for medical abortion
- Gestational age above 63 days based on LMP
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site
Scientific-Research Institute of Obstetrics and Gynecology
Baku, 1065
About this study
Official title: Safety and Acceptability of Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.
The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.
Read the detailed description
The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.
- Conditions
- Pregnancy Related
- Being tested
- Medical Abortion
- Keywords
- Telemedicine, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical AbortionDrug
Medical Abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse events resulting from the remote provision of medical abortion
Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion.
Measured: 6 weeks
Secondary outcomes (1)
Satisfaction with remote provision of medical abortion
Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using a 1-5 score system. 1 being very satisfied and 5 being very unsatisfied. A higher score means a worse outcome.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Institute of Obstetrics and Gynecology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459142
- Sponsor's protocol ID
- 1057
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No