Chart Review Study of Medical Abortion

Abortion, Medical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841072
• Other study ID #: 1029
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 20, 2016
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abortion, Medical

Locations

Country	Name	City	State
United States	Family Planning Associates- Downtown Chicago	Chicago	Illinois
United States	Family Planning Associates- Northwest Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abortion Success	Defined as a complete abortion without use of surgery	1 week	No
Primary	Serious complications	Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death	1 month	Yes
Secondary	Proportion of ongoing pregnancies	Proportion of ongoing pregnancies after the initially dispensed mife-miso	1 week	No
Secondary	Proportion of complete abortions without additional treatment	Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso	1 week	No
Secondary	Proportion of significant abortion complications	Proportion of significant abortion complications, including diagnosis of receipt of treatment for an abortion-related problem at an emergency department or urgent care center	1 month	Yes