Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Ushma Upadhyay, PhD, MPH
Photo of Ushma Upadhyay
Ushma Upadhyay

Description

Summary

This study aims to assess efficacy and safety outcomes of a model of abortion care implemented in response to the COVID-19 pandemic. The study involves telehealth for counseling and information, to maintain social distancing, but requires participants to pick up their medications in the clinic in keeping with the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategy (REMS) requirements. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.

Keywords

Abortion Early Telemedicine Telehealth Telephone Remote Telehealth Consultation

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Able to read and write in English or Spanish
  2. Currently pregnant (self-confirmed through pregnancy test result and/or ultrasound)
  3. At least 18 years old
  4. Clear and confident in the decision to obtain abortion care
  5. Seeking a medication abortion
  6. Have a history of regular menstrual cycles (between 24-38 days)
  7. Be certain of the date of their last normal menstrual period within 1 or 2 days (or have had an ultrasound demonstrating gestational age <70 days)
  8. Have a date of last menstrual period that is <56 days at enrollment (despite the label indicating eligibility up to 70 days LMP) (or have had an ultrasound demonstrating gestational age <70 days)
  9. Meet inclusion criteria based on the mifepristone label
  10. . Willing and able to visit one of the participating clinic sites

You CAN'T join if...

  1. Not pregnant
  2. Under 18 years old
  3. Not interested in medication abortion
  4. Not able to visit one of the designated pick-up clinic sites
  5. Unsure about abortion decision
  6. Contraindications to mifepristone or misoprostol
  7. Have a date of last menstrual period that is >56 days at enrollment (unless they have an ultrasound demonstrating gestational age <70 days)
  8. Significant risk factors for ectopic pregnancy (in the absence of an ultrasound confirming an intrauterine pregnancy)
  9. Signs or symptoms suggestive of ectopic pregnancy (in the absence of an ultrasound confirming an intrauterine pregnancy)
  10. . Presence of a condition or abnormality that in the opinion of the clinician Investigator would compromise the safety of the patient.

Location

  • Mt. Zion Women's Options Center
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Ushma Upadhyay, PhD, MPH
    My work encompasses two overarching themes: the effects of women's empowerment and gender equity on reproductive health and improving reproductive health services for disadvantaged populations. My methodological expertise is in quantitative analyses using epidemiologic and demographic methods.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04432792
Study Type
Interventional
Last Updated