Chart Review Study of Medical Abortion

NCT ID: NCT02841072

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

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Abortion, Medical

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Raymond, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Family Planning Associates- Northwest Chicago

Chicago, Illinois, United States

Site Status

Family Planning Associates- Downtown Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1029

Identifier Type: -

Identifier Source: org_study_id

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