Medical AbortionNCT01856777
Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy
A study testing Semi-quantitative panel test and High sensitivity urine pregnancy test in people with Medical Abortion, run by Gynuity Health Projects at 2 sites in Vietnam.
Trial summary
This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Semi-quantitative panel test and High sensitivity urine pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesVietnam
- Study dates
- Jun 2013to Feb 2014
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≤63days from LMP
- Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
- Willing to follow instructions of the provider regarding use of the pregnancy tests
- Able to read and write to use pregnancy test at home
- Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
- Willing to provide an address and/or telephone number for purposes of follow-up
Show all 9Show fewer
- Agrees to return for follow-up visit at clinic to confirm abortion status
- Wishes to participate in the study
- Able to consent to study participation
Who cannot join
- Women not meeting the above inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Hocmon General District Hospital
Hochiminh City
Hungvuong Hospital
Hochiminh City
About this study
Official title: Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion
This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).
- The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
- The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
- The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
- Conditions
- Medical Abortion
- Being tested
- Semi-quantitative panel test, High sensitivity urine pregnancy test
- Keywords
- Medical Abortion, Pregnancy Test, continuing pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-quantitative panel testDevice
Also called dBest (AmeriTek, Seattle WA, USA)
High sensitivity urine pregnancy testDevice
Also called Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA
| Study group | Role | What they receive |
|---|---|---|
| High sensitivity urine pregnancy test | Other | Standard medical care and high sensitivity urine pregnancy test Receives: Device: High sensitivity urine pregnancy test |
| Semi-quantitative panel test | Other | Standard medical care and semi-quantitative panel test Receives: Device: Semi-quantitative panel test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of these two types of home pregnancy tests
Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.
Measured: 2 weeks
Secondary outcomes (3)
Comparison of the two types of pregnancy tests at identifying continuing pregnancy
Measured: 2 weeks
The use and acceptability of the two tests
The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion
Measured: 2 weeks
Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsNguyen Thi Nhu Ngoc, MD, MsC, Principal investigator, CRCRHPaul Blumenthal, MD, Principal investigator, Stanford UniversityWendy Sheldon, MPH, MSW, PhD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856777
- Sponsor's protocol ID
- 6003
- Status last verified
- May 2014
- First submitted
- 3 May 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion
- ClinicalTrials.gov ID
- NCT01856777
- Acronym / sponsor ID
- 6003
- Conditions
- Medical Abortion
- Keywords
- Medical Abortion, Pregnancy Test, continuing pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 May 2013 (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 randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).
- The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
- The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
- The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High sensitivity urine pregnancy test | Other | Device: High sensitivity urine pregnancy testStandard medical care and high sensitivity urine pregnancy test |
| Semi-quantitative panel test | Other | Device: Semi-quantitative panel testStandard medical care and semi-quantitative panel test |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Gestational age ≤63days from LMP
- Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
- Willing to follow instructions of the provider regarding use of the pregnancy tests
- Able to read and write to use pregnancy test at home
- Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
Key exclusion criteria (1 listed)
- Women not meeting the above 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-quantitative panel testAlso: dBest (AmeriTek, Seattle WA, USA) | Device | Semi-quantitative panel test |
| High sensitivity urine pregnancy testAlso: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA | Device | High sensitivity urine pregnancy test |
Primary outcome
Accuracy of these two types of home pregnancy tests
Time frame: 2 weeks
Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration.
3 secondary outcomes
Comparison of the two types of pregnancy tests at identifying continuing pregnancy
Time frame: 2 weeks
The use and acceptability of the two tests
Time frame: 2 weeks
Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider
Time frame: 2 weeks
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 14 May 2014.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Nguyen Thi Nhu Ngoc, MD, MsC principal investigator
CRCRH
Paul Blumenthal, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-quantitative panel test and High sensitivity urine pregnancy test in people with Medical Abortion, run by Gynuity Health Projects at 2 sites in Vietnam.
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 9 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 14 May 2014. 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 Vietnam. 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?
Accuracy of these two types of home pregnancy tests (time frame: 2 weeks). 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 14 May 2014.