Legally Induced Abortion, Complete, Without Mention of ComplicationNCT01362387
R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion
A study testing Alternative follow-up protocol in people with Legally Induced Abortion, Complete, Without Mention of Complication, run by Gynuity Health Projects at 4 sites in United Kingdom.
Trial summary
Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Legally Induced Abortion, Complete, Without Mention of Complication
- What is being tested?
- Alternative follow-up protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2011to Dec 2011
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 16 years of age or older,
- eligible for an abortion under the terms of the Abortion Act (1967),
- requesting an early medical abortion,
- willing and able to comply with the study protocol and visit schedule,
- access to either a mobile phone, intranet or telephone and willing to have communication by one of these means to assess post-medical abortion status,
- willing to have call back messages left,
- willing and able to provide valid informed consent, and
- able to communicate in English.
Who cannot join
- prior participation in this research study, or
- current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Birmingham Day Care Unit
Birmingham
Chester Day Care Unit
Chester
London Central Day Care Unit
London
Luton Day Care Unit
Luton
About this study
Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and ultrasound scan or a telephone call and high sensitivity pregnancy test.
Hypothesis: The use of "alternative" methods to assess outcomes after early medical abortion will achieve a higher rate of follow-up than women undergoing "standard" follow-up
Read more
Primary aim: To determine the follow-up rate after early medical abortion with an alternative protocol as compared to a standard follow-up protocol
Secondary aims:
- To assess complication rates and receipt of further treatment among women in the two study arms
- To ascertain women's preferences for mode of communication regarding their post-medical abortion status
- To determine provider opinions and preferences for different follow-up modalities
- Being tested
- Alternative follow-up protocol
- Keywords
- Medical abortion, abortion follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative follow-up protocolOther
Women (n=1000) will be allocated by chance to one of two groups: alternative follow-up using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test, or standard follow-up which consists of an in person visit with an ultrasound or a telephone call and high sensitivity pregnancy test.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Women assigned to Group 1 will receive the standard post-abortion follow-up currently used at bpas and will be undertaken as usual by staff at the treating clinic |
| Group 2 | Experimental | Follow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test. Receives: Other: Alternative follow-up protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women with complete clinical information on post-abortion status
The primary purpose of this trial is to compare the ability of the two systems to identify the number of women who require additional medical abortion-related care.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legally Induced Abortion, Complete, Without Mention of ComplicationStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- British Pregnancy Advisory Service
- Responsible party
- Sponsor
- Investigators
- Hillary Bracken, PhD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362387
- Sponsor's protocol ID
- 1.4.3
- Status last verified
- May 2011
- First submitted
- 2 May 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion
- ClinicalTrials.gov ID
- NCT01362387
- Acronym / sponsor ID
- 1.4.3
- Keywords
- Medical abortion, abortion follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- British Pregnancy Advisory Service
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 May 2011 (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.
Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and ultrasound scan or a telephone call and high sensitivity pregnancy test.
Hypothesis: The use of "alternative" methods to assess outcomes after early medical abortion will achieve a higher rate of follow-up than women undergoing "standard" follow-up
Primary aim: To determine the follow-up rate after early medical abortion with an alternative protocol as compared to a standard follow-up protocol
Secondary aims:
- To assess complication rates and receipt of further treatment among women in the two study arms
- To ascertain women's preferences for mode of communication regarding their post-medical abortion status
- To determine provider opinions and preferences for different follow-up modalities
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Women assigned to Group 1 will receive the standard post-abortion follow-up currently used at bpas and will be undertaken as usual by staff at the treating clinic |
| Group 2 | Experimental | Other: Alternative follow-up protocolFollow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 16 years of age or older,
- eligible for an abortion under the terms of the Abortion Act (1967),
- requesting an early medical abortion,
- willing and able to comply with the study protocol and visit schedule,
- access to either a mobile phone, intranet or telephone and willing to have communication by one of these means to assess post-medical abortion status,
Key exclusion criteria (2 listed)
- prior participation in this research study, or
- current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
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 |
|---|---|---|
| Alternative follow-up protocolWomen (n=1000) will be allocated by chance to one of two groups: alternative follow-up using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test, or standard follow-up which consists of an in person visit with an ultrasound or a telephone call and high sensitivity pregnancy test. | Other | Group 2 |
Primary outcome
Number of women with complete clinical information on post-abortion status
Time frame: 14 days
The primary purpose of this trial is to compare the ability of the two systems to identify the number of women who require additional medical abortion-related care.
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 15 Feb 2013.
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.
Hillary Bracken, PhD principal investigator
Gynuity Health Projects
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative follow-up protocol in people with Legally Induced Abortion, Complete, Without Mention of Complication, run by Gynuity Health Projects at 4 sites in United Kingdom.
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 8 inclusion and 2 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Number of women with complete clinical information on post-abortion status (time frame: 14 days). 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 15 Feb 2013.