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Feasibility of Medical Abortion by Telemedicine in Mexico

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931460
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:
This study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico.

Condition or disease Intervention/treatment
Pregnancy Drug: Medical Abortion

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Medical Abortion by Telemedicine in Mexico
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Groups and Cohorts
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Intervention Details:
  • Drug: Medical Abortion
    Medical Abortion

Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
    Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women seeking abortion
Criteria

Inclusion Criteria:

  • Woman is pregnant and desires a medical abortion by remote consult (TeleILE)
  • 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:

  • Medically ineligible for procedure.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931460


Contacts
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Contact: Melanie Pena, MPH, MA (212) 448-1230 mpena@gynuity.org
Contact: Manuel Bousiéguez, MBA (212) 448-1230 mbousieguez@gynuity.org

Locations
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Mexico
Clinica AMASS Not yet recruiting
San Cristobal de las Casas, Chiapas, Mexico
Contact: Karla Mercado Gonzalez, MD    55-4576-4241      
Principal Investigator: Laura Miranda Arteaga, MD         
Servicios Humanitarios en Salud Sexual y Reproductiva (SHSSR) Not yet recruiting
Merida, Yucatan, Mexico
Contact: Sandra Peniche Quintal, MD    999-127-8275      
Principal Investigator: Sandra Peniche Quintal, MD         
Atención Integral en Ginecología,Medieg A.C. Recruiting
Mexico City, Mexico, 03100
Contact: Irving Geovanni Ortiz Salgado    55 5068-1903      
Principal Investigator: César Ruiz Cruz, MD         
Centro de Atención Integral a la Pareja, A.C. (CIPA) Recruiting
Mexico City, Mexico, 04460
Contact: Andrea Cruz Guerrero    55 4937 3252      
Principal Investigator: Ana María Camarillo, MD         
Gineclinic Recruiting
Mexico City, Mexico
Contact: Saraheli Lara, RN    55-4554-6209      
Principal Investigator: Karla Figueroa, MD         
Sponsors and Collaborators
Gynuity Health Projects
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03931460    
Other Study ID Numbers: 1045
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No