Medical; Abortion, FetusNCT02381223
Simplified Medical Abortion Screening: A Pilot Demonstration Project
An observational study of Medical; Abortion, Fetus, run by Gynuity Health Projects at 5 sites in 3 countries.
Trial summary
This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical; Abortion, Fetus
- How many people
- 409 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2015to Jan 2017
- 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: Female: only female participants are being studied
Who may be able to join
- Women having medical abortion
Who cannot join
None listed.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Carafem
Friendship Heights, Maryland, 20815
Planned Parenthood Minnesota, North Dakota, South Dakora
Minneapolis, Minnesota, 55114
Institute for Family Health
New York, New York, 10003
About this study
This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.
- Conditions
- Medical; Abortion, Fetus
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical; Abortion, FetusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, MD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381223
- Sponsor's protocol ID
- 1020
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2015
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Raymond EG, Tan YL, Comendant R, Sagaidac I, Hodorogea S, Grant M, Sanhueza P, Van Pratt E, Gillespie G, Boraas C, Weaver MA, Platais I, Bousieguez M, Winikoff B. Simplified medical abortion screening: a demonstration project. Contraception. 2018 Apr;97(4):292-296. doi: 10.1016/j.contraception.2017.11.005. Epub 2017 Nov 21.
PubMed 29170088
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Medical Abortion Screening: A Pilot Demonstration Project
- ClinicalTrials.gov ID
- NCT02381223
- Acronym / sponsor ID
- 1020
- Conditions
- Medical; Abortion, Fetus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Mar 2015 (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.
This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female: only female participants are being studied
Key inclusion criteria (1 listed)
- Women having medical abortion
Key exclusion criteria (0 listed)
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
Incidence of serious adverse events
Time frame: 7 days
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 1 May 2017.
- Derived from this study: PubMed 29170088Raymond EG, Tan YL, Comendant R, Sagaidac I, Hodorogea S, Grant M, Sanhueza P, Van Pratt E, Gillespie G, Boraas C, Weaver MA, Platais I, Bousieguez M, Winikoff B. Simplified medical abortion screening: a demonstration project. Contraception. 2018 Apr;97(4):292-296. doi: 10.1016/j.contraception.2017.11.005. Epub 2017 Nov 21.
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 principal investigator
Gynuity Health Projects
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical; Abortion, Fetus, run by Gynuity Health Projects at 5 sites in 3 countries.
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 1 inclusion and 0 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Mexico, Moldova. 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?
Incidence of serious adverse events (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381223, which also lists 1 linked publication.
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 1 May 2017.