Completion of Medical Abortionm-Assist+NCT02231619
Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion
A study testing Baseline verbal instruction on LSUPT in people with Completion of Medical Abortion, run by University of Cape Town at 1 site in South Africa.
Trial summary
The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Completion of Medical Abortion
- What is being tested?
- Baseline verbal instruction on LSUPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2014to Oct 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Already be signed up to do a medical abortion at this clinic
- Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study
- Own a cellphone to which will be sent medical abortion-related information and messaging.
Who cannot join
- 1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working cellphone
- -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Nolungile Youth Clinic, Khayelitsha
Cape Town, Western Province
About this study
Official title: The Feasibility of Replacing In-person Follow-up for Early Medical Abortion With a Low Sensitivity Pregnancy Test, Symptom Checklist and Text Messages in the South African Public Sector Setting.
The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.
- Conditions
- Completion of Medical Abortion
- Being tested
- Baseline verbal instruction on LSUPT
- Keywords
- feasibility, self assessment, medical abortion, low sensitivity urine pregnancy test, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline verbal instruction on LSUPTBehavioural
Also called Low sensitivity urine pregnancy test
| Study group | Role | What they receive |
|---|---|---|
| Demonstration of LSUPT at baseline | No intervention | This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker. |
| Baseline verbal instruction of LSUPT | Active comparator | Verbal instruction on how to do LSUPT at baseline Receives: Behavioral: Baseline verbal instruction on LSUPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test
Participants will be randomized to 2 groups. Women in Group A will conduct a baseline low sensitivity urine pregnancy test (LSUPT) on their own urine specimen at their clinic visit with help from the fieldworker. Group B will receive a standardized set of verbal instructions on how to do the test. Both groups will do a LSUPT at home on Day 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionOct 2015
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 Completion of Medical 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Deborah Constant, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231619
- Sponsor's protocol ID
- 677/2013
- Acronym
- m-Assist+
- Status last verified
- Nov 2015
- First submitted
- 31 Aug 2014
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Constant D, Harries J, Daskilewicz K, Myer L, Gemzell-Danielsson K. Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial. PLoS One. 2017 Jun 22;12(6):e0179600. doi: 10.1371/journal.pone.0179600. eCollection 2017.
PubMed 28640845
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Replacing In-person Follow-up for Early Medical Abortion With a Low Sensitivity Pregnancy Test, Symptom Checklist and Text Messages in the South African Public Sector Setting.
- ClinicalTrials.gov ID
- NCT02231619
- Acronym / sponsor ID
- m-Assist+ / 677/2013
- Conditions
- Completion of Medical Abortion
- Keywords
- feasibility, self assessment, medical abortion, low sensitivity urine pregnancy test, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Sep 2014 (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 the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Demonstration of LSUPT at baseline | No intervention | –This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker. |
| Baseline verbal instruction of LSUPT | Active comparator | Behavioral: Baseline verbal instruction on LSUPTVerbal instruction on how to do LSUPT at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Already be signed up to do a medical abortion at this clinic
- Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study
- Own a cellphone to which will be sent medical abortion-related information and messaging.
Key exclusion criteria (2 listed)
- 1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working cellphone
- -
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 |
|---|---|---|
| Baseline verbal instruction on LSUPTAlso: Low sensitivity urine pregnancy test | Behavioural | Baseline verbal instruction of LSUPT |
Primary outcome
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test
Time frame: 12 months
Participants will be randomized to 2 groups. Women in Group A will conduct a baseline low sensitivity urine pregnancy test (LSUPT) on their own urine specimen at their clinic visit with help from the fieldworker. Group B will receive a standardized set of verbal instructions on how to do the test. Both groups will do a LSUPT at home on Day 12.
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 9 Nov 2015.
- Derived from this study: PubMed 28640845Constant D, Harries J, Daskilewicz K, Myer L, Gemzell-Danielsson K. Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial. PLoS One. 2017 Jun 22;12(6):e0179600. doi: 10.1371/journal.pone.0179600. eCollection 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline verbal instruction on LSUPT in people with Completion of Medical Abortion, run by University of Cape Town at 1 site in South Africa.
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 3 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 9 Nov 2015. 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 South Africa. 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?
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test (time frame: 12 months). 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 NCT02231619, 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 9 Nov 2015.