Feasibility of Medical Abortion by Telemedicine in Mexico
Condition: Pregnancy
Study type: Observational

Summary: 
      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.
    

Intervention name(s): Medical Abortion
Intervention type(s): Drug
Intervention description(s): Medical Abortion
Other intervention name(s): Medication abortion, abortion with pills
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women seeking abortion