Chart Review Study of Medical Abortion

Completed

• Conditions: Abortion, Medical

• Registration Number: NCT02841072
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 579

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abortion Success	1 week	Defined as a complete abortion without use of surgery
Serious complications	1 month	Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death

Secondary Outcome Measures

Name	Time	Method
Proportion of ongoing pregnancies	1 week	Proportion of ongoing pregnancies after the initially dispensed mife-miso
Proportion of complete abortions without additional treatment	1 week	Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso
Proportion of significant abortion complications	1 month	Proportion of significant abortion complications, including diagnosis of receipt of treatment for an abortion-related problem at an emergency department or urgent care center

Trial Locations

Locations (2)

Family Planning Associates- Northwest Chicago; 🇺🇸 Chicago, Illinois, United States

Family Planning Associates- Downtown Chicago; 🇺🇸 Chicago, Illinois, United States