Medical AbortionPhase 3NCT01150422
The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
A Phase 3 study testing Alternative follow-up in people with Medical Abortion, run by Gynuity Health Projects at 4 sites in Vietnam.
Trial summary
This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam… Read more about this study
- Who is it for?
- Ages 13 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Alternative follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 4 sitesVietnam
- Study dates
- Apr 2010to Apr 2011
- Phase
- Phase 3
- 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 13 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Reproductive age women seeking medical abortion services
- Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Hold a working, personal phone number
- be willing and able to sign consent forms and agree to comply with study procedures
Who cannot join
- Pregnancy greater than 63 days gestation on the day of mifepristone administration
Trial locations and contacts
4 sites in 1 country.
Vietnam4 sites
Hanoi Ob-Gyn Hospital
Hanoi
National Ob-Gyn Hospital
Hanoi
HocMon District Hospital
Ho Chi Minh City
Hung Vuong Hospital
Ho Chi Minh City
About this study
Official title: The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.
The goal of the study is to provide answers to the following questions:
- Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
- Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
- Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?
- Conditions
- Medical Abortion
- Being tested
- Alternative follow-up
- Keywords
- medical abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative follow-upOther
After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit. During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care for post medical abortion follow-up | No intervention | Standard of care includes a routine hospital visit two weeks after mifepristone administration. At the hospital visit, the woman will undergo a bimanual and vaginal ultrasound examination. In the event the woman fails to return for the follow-up visit, each hospital will follow their standard procedure for contacting women who fail to attend their follow-up visit, i.e. three efforts to contact the woman. Form 2a will document the results of any clinical examinations, any additional medical abortion-related care given and the abortion outcome. At the follow-up visit, women will also be asked about the acceptability of current medical abortion follow-up procedures and their future preferences. |
| Alternative follow-up | Active comparator | At their first clinic visit, women will be asked to provide their phone number for contact purposes. Women will also be asked to complete a semi-quantitative pregnancy test in the clinic and the results of the test will be noted on a study form. After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist.
Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned date two weeks after mifepristone administration. The checklist will indicate that if the woman answers "yes" to any of the questions, then she should return to the clinic for a follow-up visit. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. Receives: Other: Alternative follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continued, ongoing pregnancy
Measured: 9 months
Secondary outcomes (2)
percentage of women who return for follow-up
Measured: 9 months
percentage of women receiving other treatment for ongoing pregnancy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Investigators
- Nguyen Thi Nhu Ngoc, MD, MSc, Principal investigator, Center for Research and Consultancy in Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150422
- Sponsor's protocol ID
- 6.4
- Status last verified
- Apr 2011
- First submitted
- 7 May 2010
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ngoc NTN, Bracken H, Blum J, Nga NTB, Minh NH, van Nhang N, Lynd K, Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):88-95. doi: 10.1097/AOG.0000000000000050.
PubMed 24463668
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
- ClinicalTrials.gov ID
- NCT01150422
- Acronym / sponsor ID
- 6.4
- Conditions
- Medical Abortion
- Keywords
- medical abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Jun 2010 (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 trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.
The goal of the study is to provide answers to the following questions:
- Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
- Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
- Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care for post medical abortion follow-up | No intervention | –Standard of care includes a routine hospital visit two weeks after mifepristone administration. At the hospital visit, the woman will undergo a bimanual and vaginal ultrasound examination. In the event the woman fails to return for the follow-up visit, each hospital will follow their standard procedure for contacting women who fail to attend their follow-up visit, i.e. three efforts to contact the woman. Form 2a will document the results of any clinical examinations, any additional medical abortion-related care given and the abortion outcome. At the follow-up visit, women will also be asked about the acceptability of current medical abortion follow-up procedures and their future preferences. |
| Alternative follow-up | Active comparator | Other: Alternative follow-upAt their first clinic visit, women will be asked to provide their phone number for contact purposes. Women will also be asked to complete a semi-quantitative pregnancy test in the clinic and the results of the test will be noted on a study form. After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned date two weeks after mifepristone administration. The checklist will indicate that if the woman answers "yes" to any of the questions, then she should return to the clinic for a follow-up visit. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Reproductive age women seeking medical abortion services
- Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Hold a working, personal phone number
- be willing and able to sign consent forms and agree to comply with study procedures
Key exclusion criteria (1 listed)
- Pregnancy greater than 63 days gestation on the day of mifepristone administration
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-upAfter mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit. During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure. | Other | Alternative follow-up |
Primary outcome
Continued, ongoing pregnancy
Time frame: 9 months
2 secondary outcomes
percentage of women who return for follow-up
Time frame: 9 months
percentage of women receiving other treatment for ongoing pregnancy
Time frame: 9 months
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 2 May 2011.
- Derived from this study: PubMed 24463668Ngoc NTN, Bracken H, Blum J, Nga NTB, Minh NH, van Nhang N, Lynd K, Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):88-95. doi: 10.1097/AOG.0000000000000050.
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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.
Nguyen Thi Nhu Ngoc, MD, MSc principal investigator
Center for Research and Consultancy in Reproductive Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alternative follow-up in people with Medical Abortion, run by Gynuity Health Projects at 4 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 4 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 2 May 2011. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Continued, ongoing pregnancy (time frame: 9 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 NCT01150422, 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 2 May 2011.