Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 59 for:    abortion , gynuity

Chart Review Study of Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841072
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Abortion, Medical

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Chart Review Study of Medical Abortion at 64-70 Days of Gestation
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016



Primary Outcome Measures :
  1. Abortion Success [ Time Frame: 1 week ]
    Defined as a complete abortion without use of surgery

  2. Serious complications [ Time Frame: 1 month ]
    Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death


Secondary Outcome Measures :
  1. Proportion of ongoing pregnancies [ Time Frame: 1 week ]
    Proportion of ongoing pregnancies after the initially dispensed mife-miso

  2. Proportion of complete abortions without additional treatment [ Time Frame: 1 week ]
    Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso

  3. Proportion of significant abortion complications [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841072


Locations
Layout table for location information
United States, Illinois
Family Planning Associates- Northwest Chicago
Chicago, Illinois, United States, 60630
Family Planning Associates- Downtown Chicago
Chicago, Illinois, United States, 60661
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects

Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02841072     History of Changes
Other Study ID Numbers: 1029
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016