Abortion, MedicalNCT02841072
Chart Review Study of Medical Abortion
An observational study of Abortion, Medical, run by Gynuity Health Projects at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Medical
- How many people
- 579 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Women at 64-70 days of gestation
- Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion
Who cannot join
- Does not meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Planning Associates- Northwest Chicago
Chicago, Illinois, 60630
Family Planning Associates- Downtown Chicago
Chicago, Illinois, 60661
About this study
Official title: Chart Review Study of Medical Abortion at 64-70 Days of Gestation
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.
Read the 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.
- Conditions
- Abortion, Medical
What is being measured
The primary outcome is the main question the study is designed to answer.
Abortion Success
Defined as a complete abortion without use of surgery
Measured: 1 week
Serious complications
Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death
Measured: 1 month
Secondary outcomes (3)
Proportion of ongoing pregnancies
Proportion of ongoing pregnancies after the initially dispensed mife-miso
Measured: 1 week
Proportion of complete abortions without additional treatment
Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso
Measured: 1 week
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MedicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841072
- Sponsor's protocol ID
- 1029
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chart Review Study of Medical Abortion at 64-70 Days of Gestation
- ClinicalTrials.gov ID
- NCT02841072
- Acronym / sponsor ID
- 1029
- Conditions
- Abortion, Medical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Women at 64-70 days of gestation
- Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Abortion Success
Time frame: 1 week
Defined as a complete abortion without use of surgery
Serious complications
Time frame: 1 month
Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death
3 secondary outcomes
Proportion of ongoing pregnancies
Time frame: 1 week
Proportion of complete abortions without additional treatment
Time frame: 1 week
Proportion of significant abortion complications
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
Related trials for Abortion, Medical
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruiting
'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial
Medical Abortion
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Raymond, MD, MPH principal investigator
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Medical, run by Gynuity Health Projects at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abortion Success (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.