Feasibility of Medical Abortion by Telemedicine in Mexico
NCT ID: NCT03931460
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1114 participants
OBSERVATIONAL
2019-04-01
2023-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Medical Abortion
Medical Abortion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
10 Years
50 Years
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Beverly B Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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Telefem
Mexico City, Mexico City, Mexico
Atención Integral en Ginecología,Medieg A.C.
Mexico City, , Mexico
Centro de Atención Integral a la Pareja, A.C. (CIPA)
Mexico City, , Mexico
Gineclinic
Mexico City, , Mexico
MUSOR
Oaxaca City, , Mexico
Countries
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Other Identifiers
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1045
Identifier Type: -
Identifier Source: org_study_id