PregnancyPhase 2/3NCT02299401
Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up
A Phase 2/3 study testing Misoprostol and Semi-quantitative pregnancy test in people with Pregnancy, run by Gynuity Health Projects at 2 sites in 2 countries.
Trial summary
This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Misoprostol and Semi-quantitative pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2014to Oct 2016
- Phase
- Phase 2/3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presents for voluntary termination of pregnancy
- Gestational age ≤ 70 days by last menstrual period plus clinical assessment or ultrasound
- General good health including the absence of conditions which contraindicate the use of misoprostol for pregnancy termination
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for the purposes of follow-up
- Able to consent to study participation
Who cannot join
- Gestational age > 70 days last menstrual period
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion include having an intrauterine device in place and history of allergy to misoprostol or other prostaglandins
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.
- Conditions
- Pregnancy
- Being tested
- Misoprostol, Semi-quantitative pregnancy test
- Keywords
- Medical abortion, Induced abortion, Pregnancy test, Semi-quantitative pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Women will receive three 800 mcg doses of misoprostol.
Semi-quantitative pregnancy testDevice
Also called SQPT
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Buccal | Experimental | Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. Receives: Drug: Misoprostol; Device: Semi-quantitative pregnancy test |
| Sublingual | Experimental | Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. Receives: Drug: Misoprostol; Device: Semi-quantitative pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rates
The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.
Measured: 1-2 weeks
Secondary outcomes (4)
Incidence of side effects and complications as a measure of safety/ side effects
Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination.
Measured: 1-2 weeks
Reported acceptability and satisfaction with misoprostol regimen
The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women.
Measured: 1-2 weeks
Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home
The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure.
Measured: 1-2 weeks
Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up
The study will also assess the acceptability of the test as a means for at-home follow-up after medical abortion as rated by the women. The woman will answer questions about whether she found the SQPT easy to use an acceptable for at-home follow up.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionOct 2016
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 PregnancyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy R Sheldon, PhD, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299401
- Sponsor's protocol ID
- 6006
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2014
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.
PubMed 30831103
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
- ClinicalTrials.gov ID
- NCT02299401
- Acronym / sponsor ID
- 6006
- Conditions
- Pregnancy
- Keywords
- Medical abortion, Induced abortion, Pregnancy test, Semi-quantitative pregnancy test
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Nov 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.
This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal | Experimental | Drug: Misoprostol, Device: Semi-quantitative pregnancy testWomen randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. |
| Sublingual | Experimental | Drug: Misoprostol, Device: Semi-quantitative pregnancy testWomen randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Presents for voluntary termination of pregnancy
- Gestational age ≤ 70 days by last menstrual period plus clinical assessment or ultrasound
- General good health including the absence of conditions which contraindicate the use of misoprostol for pregnancy termination
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for the purposes of follow-up
- Able to consent to study participation
Key exclusion criteria (3 listed)
- Gestational age > 70 days last menstrual period
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion include having an intrauterine device in place and history of allergy to misoprostol or other prostaglandins
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 |
|---|---|---|
| MisoprostolWomen will receive three 800 mcg doses of misoprostol. | Drug | Buccal, Sublingual |
| Semi-quantitative pregnancy testAlso: SQPTAll women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up. | Device | Buccal, Sublingual |
Primary outcome
Ongoing pregnancy rates
Time frame: 1-2 weeks
The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.
4 secondary outcomes
Incidence of side effects and complications as a measure of safety/ side effects
Time frame: 1-2 weeks
Reported acceptability and satisfaction with misoprostol regimen
Time frame: 1-2 weeks
Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home
Time frame: 1-2 weeks
Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up
Time frame: 1-2 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 3 Nov 2016.
- Derived from this study: PubMed 30831103Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.
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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.
Wendy R Sheldon, PhD study director
Gynuity Health Projects
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Misoprostol and Semi-quantitative pregnancy test in people with Pregnancy, run by Gynuity Health Projects at 2 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 5 inclusion and 3 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 Nov 2016. 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 Bolivia, Ecuador. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Ongoing pregnancy rates (time frame: 1-2 weeks). 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 NCT02299401, 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 Nov 2016.