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Completed

NCT Number: NCT02841072

Chart Review Study of Medical Abortion

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.

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Key information

Conditions

Abortion, Medical

Sex eligibility

Female

Study type

Observational

Primary location

Family Planning Associates- Downtown Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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