Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03931460 |
| Other study ID # |
1045 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Gynuity Health Projects |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is designed to obtain preliminary data on the safety, acceptability, and
feasibility of direct-to-consumer telemedicine abortion in Mexico.
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.
