PregnancyNCT03931460
Feasibility of Medical Abortion by Telemedicine in Mexico
An observational study of Pregnancy, run by Gynuity Health Projects at 5 sites in Mexico.
Trial summary
This study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico. Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Medical Abortion
- Type of treatment
- Pill or oral medicine
- How many people
- 1,114 participants
- Where
- 5 sitesMexico
- Study dates
- 1 Apr 2019to 31 Aug 2023
- 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 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women seeking abortion
Who may be able to join
- Woman is pregnant and desires a medical abortion by remote consult (TeleAborto)
- Woman has access to internet or equipment for a remote consult
- Woman can provide address to which abortifacient medications will be mailed
- Woman reports no contraindications to medical abortion
- The study site does not suspect an ectopic pregnancy or nonviable pregnancy
- The gestational age allows sufficient time for the woman to take the mifepristone on or before 70 days of gestation
- A feasible plan is made that the woman agrees to confirm complete abortion and to seek care to manage incomplete abortion complications
- The woman understands and is likely to comply with study instructions and has granted informed consent to participate in the study.
Who cannot join
- Medically ineligible for procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Telefem
Mexico City, Mexico City
Atención Integral en Ginecología,Medieg A.C.
Mexico City, 03100
Centro de Atención Integral a la Pareja, A.C. (CIPA)
Mexico City, 04460
Gineclinic
Mexico City
MUSOR
Oaxaca City
About this study
This study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico.
Read the detailed description
This is a case-series prospective study to develop, implement, and evaluate a telemedicine medical abortion service in private sector health facilities in Mexico. The service will be designed to incorporate the standard steps in an in-person medical abortion procedure, thus ensuring that the quality of care provided to each woman is equal to that which she would receive if she presented in person to an abortion facility.
Individuals determined as likely to be eligible will have a "TelEvaluation" by videoconference, telephone, messaging, or a combination of these, with a study provider who will give standard pre-abortion counseling and explain study procedures and the process of obtaining informed consent for the study. The informed consent form will be either signed electronically using secure software, or by printing the form, signing, scanning, and returning it to the study site; oral consent recorded by telephone will be also an option. Demographic and medical information will be recorded during the TelEvaluation. If required by the site, the provider will assist in identifying facilities to obtain any tests and have the results sent to the study site.
A person will be eligible for the study if they have no contraindications to medical abortion medications, if an intrauterine pregnancy is determined, and if the provider judge that the participant could receive and take the mifepristone at ≤70 days of gestation. If the individual is eligible and wishes to continue with the abortion, the site will send a package containing one tablet of mifepristone 200 mg, 8 tablets of misoprostol 200 mcg, and 8 tablets of ibuprofen 800 mg once payment for the service is received. Each site will determine the total cost of the service, and the package will be shipped by tracked mail or other reliable means of delivery. Distance to the clinic will be measured using a map application and the address provided by the participant for package receipt. Antibiotics, antiemetics, and contraceptives will be prescribed at the discretion of the site. The package will also include written instructions detailing medication administration, expected symptoms and side effects, the follow up plan, and emergency procedures. The regimen to be used is mifepristone 200 mg followed by misoprostol 800 mcg within 48 h administered buccally or sublingually. The participant will be instructed to take the remaining four misoprostol tablets if no bleeding occurred within 24 hours of taking the misoprostol dose.
A follow-up contact with the study provider will be scheduled for 7 to 14 days after the package is mailed to assess abortion outcome, adverse events, and other relevant information via phone interview or messaging. Study providers will use any combination of methods to determine abortion completeness including ultrasound, serum HCG, urine pregnancy test, and patient's history. If further care is indicated, the provider will refer the participant to a facility. Once it is found that the abortion is complete staff will administer a satisfaction questionnaire.
- Conditions
- Pregnancy
- Being tested
- Medical Abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical AbortionDrug
Also called Medication abortion, abortion with pills
Medical Abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Adverse Events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly B Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931460
- Sponsor's protocol ID
- 1045
- Status last verified
- Dec 2023
- First submitted
- 25 Apr 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Medical Abortion by Telemedicine in Mexico
- ClinicalTrials.gov ID
- NCT03931460
- Acronym / sponsor ID
- 1045
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 30 Apr 2019 (actual)
- 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 is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico.
Detailed description
This is a case-series prospective study to develop, implement, and evaluate a telemedicine medical abortion service in private sector health facilities in Mexico. The service will be designed to incorporate the standard steps in an in-person medical abortion procedure, thus ensuring that the quality of care provided to each woman is equal to that which she would receive if she presented in person to an abortion facility.
Individuals determined as likely to be eligible will have a "TelEvaluation" by videoconference, telephone, messaging, or a combination of these, with a study provider who will give standard pre-abortion counseling and explain study procedures and the process of obtaining informed consent for the study. The informed consent form will be either signed electronically using secure software, or by printing the form, signing, scanning, and returning it to the study site; oral consent recorded by telephone will be also an option. Demographic and medical information will be recorded during the TelEvaluation. If required by the site, the provider will assist in identifying facilities to obtain any tests and have the results sent to the study site.
A person will be eligible for the study if they have no contraindications to medical abortion medications, if an intrauterine pregnancy is determined, and if the provider judge that the participant could receive and take the mifepristone at ≤70 days of gestation. If the individual is eligible and wishes to continue with the abortion, the site will send a package containing one tablet of mifepristone 200 mg, 8 tablets of misoprostol 200 mcg, and 8 tablets of ibuprofen 800 mg once payment for the service is received. Each site will determine the total cost of the service, and the package will be shipped by tracked mail or other reliable means of delivery. Distance to the clinic will be measured using a map application and the address provided by the participant for package receipt. Antibiotics, antiemetics, and contraceptives will be prescribed at the discretion of the site. The package will also include written instructions detailing medication administration, expected symptoms and side effects, the follow up plan, and emergency procedures. The regimen to be used is mifepristone 200 mg followed by misoprostol 800 mcg within 48 h administered buccally or sublingually. The participant will be instructed to take the remaining four misoprostol tablets if no bleeding occurred within 24 hours of taking the misoprostol dose.
A follow-up contact with the study provider will be scheduled for 7 to 14 days after the package is mailed to assess abortion outcome, adverse events, and other relevant information via phone interview or messaging. Study providers will use any combination of methods to determine abortion completeness including ultrasound, serum HCG, urine pregnancy test, and patient's history. If further care is indicated, the provider will refer the participant to a facility. Once it is found that the abortion is complete staff will administer a satisfaction questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women seeking abortion
Key inclusion criteria (8 listed)
- Woman is pregnant and desires a medical abortion by remote consult (TeleAborto)
- Woman has access to internet or equipment for a remote consult
- Woman can provide address to which abortifacient medications will be mailed
- Woman reports no contraindications to medical abortion
- The study site does not suspect an ectopic pregnancy or nonviable pregnancy
Key exclusion criteria (1 listed)
- Medically ineligible for procedure.
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 |
|---|---|---|
| Medical AbortionAlso: Medication abortion, abortion with pillsMedical Abortion | Drug | – |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 1 year
Adverse Events
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 8 Dec 2023.
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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.
Beverly B Winikoff, MD, MPH principal investigator
Gynuity Health Projects
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Gynuity Health Projects at 5 sites in Mexico.
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 8 inclusion and 1 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 8 Dec 2023. 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 Mexico. 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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 1 year). 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 8 Dec 2023.