Medical Abortion, FetusPhase 4NCT01410266
Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
A Phase 4 study testing Alternative follow-up in people with Medical Abortion, Fetus, run by Gynuity Health Projects at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion, Fetus
- What is being tested?
- Alternative follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2010to Oct 2012
- Phase
- Phase 4
- 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Reproductive-age woman seeking a medical abortion
- Woman in good general health
- Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Woman able and willing to sign consent forms
- Woman eligible for medical abortion according to clinician's assessment
- Woman agreeing to be followed up with, by phone or at a clinic visit
Who cannot join
- Woman with a pregnancy greater than 63 days gestation on the day of mifepristone administration
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Moldova4 sites
The Perinatalogy Center
Bălţi
Municipal Clinical Hospital
Chisinau
The National Center of Reproductive Health and Medical Genetics
Chisinau
The Center of Women Health "Ana"
Drochia
Uzbekistan3 sites
Clinic #2 of Tashkent Medical Academy
Tashkent
Municipal Maternity House #10
Tashkent
Women's Wellness Center
Tashkent
About this study
Official title: The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan
The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.
Read the detailed description
Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.
This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.
- Conditions
- Medical Abortion, Fetus
- Being tested
- Alternative follow-up
- Keywords
- medical abortion, first trimester, follow-up, pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative follow-upOther
Also called semi-quantitative pregnancy test, self-administered questionnaire
Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care includes a routine clinic visit two weeks after misoprostol administration. At the clinic visit, the woman undergoes a bimanual examination. In the event the woman fails to return for the follow-up visit, clinic procedure is followed for contacting her to determine abortion status and the need for further intervention, if any. |
| Alternative follow-up | Active comparator | At a clinic visit, before mifepristone administration, the woman completes a semi-quantitative pregnancy test. After mifepristone administration, she is provided with another pregnancy test and a checklist to be self-administered two weeks after she takes misoprostol. On an assigned date, the woman is contacted by phone by the clinic staff and asked to report on the results of both tests. The provider then confirms whether, based on the woman's responses, she should return for a follow-up visit. 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: 1 month
Secondary outcomes (2)
Percentage of women who return for follow-up
Measured: 1 month
Percentage of women receiving other treatment for ongoing pregnancy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
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 Abortion, FetusStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillary J. Bracken, PhD, MHS, MA, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410266
- Sponsor's protocol ID
- 6.5
- Status last verified
- Nov 2012
- First submitted
- 3 Aug 2011
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015 Feb;91(2):178-83. doi: 10.1016/j.contraception.2014.11.004. Epub 2014 Nov 15.
PubMed 25497383
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan
- ClinicalTrials.gov ID
- NCT01410266
- Acronym / sponsor ID
- 6.5
- Conditions
- Medical Abortion, Fetus
- Keywords
- medical abortion, first trimester, follow-up, pregnancy test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Aug 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.
The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.
Detailed description
Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.
This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.
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 | No intervention | –Standard of care includes a routine clinic visit two weeks after misoprostol administration. At the clinic visit, the woman undergoes a bimanual examination. In the event the woman fails to return for the follow-up visit, clinic procedure is followed for contacting her to determine abortion status and the need for further intervention, if any. |
| Alternative follow-up | Active comparator | Other: Alternative follow-upAt a clinic visit, before mifepristone administration, the woman completes a semi-quantitative pregnancy test. After mifepristone administration, she is provided with another pregnancy test and a checklist to be self-administered two weeks after she takes misoprostol. On an assigned date, the woman is contacted by phone by the clinic staff and asked to report on the results of both tests. The provider then confirms whether, based on the woman's responses, she should return for a follow-up visit. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Reproductive-age woman seeking a medical abortion
- Woman in good general health
- Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Woman able and willing to sign consent forms
- Woman eligible for medical abortion according to clinician's assessment
Key exclusion criteria (1 listed)
- Woman with a 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-upAlso: semi-quantitative pregnancy test, self-administered questionnaireAlternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed. | Other | Alternative follow-up |
Primary outcome
Continued, ongoing pregnancy
Time frame: 1 month
2 secondary outcomes
Percentage of women who return for follow-up
Time frame: 1 month
Percentage of women receiving other treatment for ongoing pregnancy
Time frame: 1 month
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 3 Dec 2012.
- Derived from this study: PubMed 25497383Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015 Feb;91(2):178-83. doi: 10.1016/j.contraception.2014.11.004. Epub 2014 Nov 15.
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 J. Bracken, PhD, MHS, MA principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alternative follow-up in people with Medical Abortion, Fetus, run by Gynuity Health Projects at 7 sites in 2 countries.
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 6 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 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Moldova, Uzbekistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 1 month). 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 NCT01410266, 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 3 Dec 2012.