NCT02841072

Chart Review Study of Medical Abortion

Chart Review Study of Medical Abortion at 64-70 Days of Gestation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 579 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Abortion, Medical

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-07-21
• Last updated: 2016-07-21

Locations

2 sites across 1 country: United States