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Chart Review Study of Medical Abortion

G

Gynuity Health Projects

Status

Completed

Conditions

Abortion, Medical

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.

Full description

The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.

Enrollment

579 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women at 64-70 days of gestation
  • Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion

Exclusion criteria

  • Does not meet the inclusion criteria

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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