AbortionNCT02524990
Simplified Medical Abortion Follow-Up
A study testing Home-based follow-up with SQPT in people with Abortion and Pregnancy Tests, run by Gynuity Health Projects at 1 site in United States.
Trial summary
The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up. Read more about this study
- Who is it for?
- Ages 11 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Pregnancy Tests
- What is being tested?
- Home-based follow-up with SQPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2015
- Phase
- Interventional
- 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 11 to 56 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
- She is willing to use the semiquantitative pregnancy test at home;
- She is wiling and able to comply with the study procedures;
- She speaks and reads English;
- She has signed the study informed consent form.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified Medical Abortion Follow-Up Study
The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.
- Conditions
- Abortion, Pregnancy Tests
- Being tested
- Home-based follow-up with SQPT
- Keywords
- Medical abortion, pregnancy tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based follow-up with SQPTBehavioural
Also called Simplified Medical Abortion Follow-Up Study
Participants will be followed-up at home. They will receive an SQPT to perform at home two weeks after enrollment, and a scheduled follow-up phone call by study providers to determine the outcome of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Home-based follow-up with SQPT | Experimental | For the intervention, a semiquantitative pregnancy test (SQPT) will be performed at the health center before the participants take mifepristone, and again two weeks later by the participants, at home. Study staff will call the participants at two weeks to follow-up with the participants. Receives: Behavioral: Home-based follow-up with SQPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' compliance in performing the semiquantitative pregnancy test and reporting results
This will be assessed with a survey administered at the scheduled follow-up phone call. The survey will determine if the patient performed the SQPT as requested, and whether they can interpret and report the results correctly.
Measured: Within 2 weeks after medical abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Integrated into another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Raymond, MD,MPH, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524990
- Sponsor's protocol ID
- 1024
- Status last verified
- Mar 2016
- First submitted
- 11 Aug 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Medical Abortion Follow-Up Study
- ClinicalTrials.gov ID
- NCT02524990
- Acronym / sponsor ID
- 1024
- Conditions
- Abortion, Pregnancy Tests
- Keywords
- Medical abortion, pregnancy tests
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Integrated into another study
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Aug 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.
The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based follow-up with SQPT | Experimental | Behavioral: Home-based follow-up with SQPTFor the intervention, a semiquantitative pregnancy test (SQPT) will be performed at the health center before the participants take mifepristone, and again two weeks later by the participants, at home. Study staff will call the participants at two weeks to follow-up with the participants. |
Who may qualify
- Ages
- 11 to 56 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
- She is willing to use the semiquantitative pregnancy test at home;
- She is wiling and able to comply with the study procedures;
- She speaks and reads English;
- She has signed the study informed consent form.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based follow-up with SQPTAlso: Simplified Medical Abortion Follow-Up StudyParticipants will be followed-up at home. They will receive an SQPT to perform at home two weeks after enrollment, and a scheduled follow-up phone call by study providers to determine the outcome of the procedure. | Behavioural | Home-based follow-up with SQPT |
Primary outcome
Patients' compliance in performing the semiquantitative pregnancy test and reporting results
Time frame: Within 2 weeks after medical abortion
This will be assessed with a survey administered at the scheduled follow-up phone call. The survey will determine if the patient performed the SQPT as requested, and whether they can interpret and report the results correctly.
Results and safety
The study was stopped early (reason given: Integrated into another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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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 study director
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based follow-up with SQPT in people with Abortion and Pregnancy Tests, run by Gynuity Health Projects at 1 site 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 5 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: stopped early, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Integrated into another study). Results are not available in the source record.
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?
Patients' compliance in performing the semiquantitative pregnancy test and reporting results (time frame: Within 2 weeks after medical abortion). 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 4 Mar 2016.