Incomplete AbortionNCT02707653
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
A study testing Misoprostol in people with Incomplete Abortion, run by Gynuity Health Projects at 2 sites in Burma.
Trial summary
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incomplete Abortion
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesBurma
- Study dates
- Mar 2016to Nov 2016
- 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 12 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Confirmed incomplete abortion
- No known contraindications to the study drug
- Uterine size no larger than 12 weeks at time of presentation for care
- No signs of severe infection, defined as at least two of the following:
- foul smelling discharge,
- fever > 38 degrees C, 100 degrees Fahrenheit
Show all 12Show fewer
- uterine tenderness.
- No hemodynamic disturbances (pulse >110/min and systolic bp <100)
- General good health
- Agree to comply with study procedures including return for follow up visit
- Live or work within one hour from a study site
- Willing and able to sign consent forms
Who cannot join
- 1. Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.
Read the detailed description
This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.
- Conditions
- Incomplete Abortion
- Being tested
- Misoprostol
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called cytotec
400 mcg sublingual misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Miso | Other | Misoprostol 400 s/l Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women with complete uterine evacuation with study medication alone.
Measured: 14 days
Secondary outcomes (2)
Percentage of women experiencing side effects
occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.
Measured: 7-14 days
Level of self-reported acceptability of treatment
Woman's satisfaction with the treatment, woman's likelihood to use the treatment in the future, woman's likelihood of recommending the treatment to a friend, providers' satisfaction with the treatment, likelihood provider would recommend the treatment in a similar situation.
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Medical Research, Lower Myanmar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707653
- Sponsor's protocol ID
- 2001
- Status last verified
- Jun 2018
- First submitted
- 19 Feb 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
- ClinicalTrials.gov ID
- NCT02707653
- Acronym / sponsor ID
- 2001
- Conditions
- Incomplete Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Department of Medical Research, Lower Myanmar
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Mar 2016 (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 study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.
Detailed description
This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miso | Other | Drug: MisoprostolMisoprostol 400 s/l |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Confirmed incomplete abortion
- No known contraindications to the study drug
- Uterine size no larger than 12 weeks at time of presentation for care
- No signs of severe infection, defined as at least two of the following:
- No hemodynamic disturbances (pulse >110/min and systolic bp <100)
Key exclusion criteria (1 listed)
- 1. Inability to provide informed consent
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 |
|---|---|---|
| MisoprostolAlso: cytotec400 mcg sublingual misoprostol | Drug | Miso |
Primary outcome
Percentage of women with complete uterine evacuation with study medication alone.
Time frame: 14 days
2 secondary outcomes
Percentage of women experiencing side effects
Time frame: 7-14 days
Level of self-reported acceptability of treatment
Time frame: 7-14 days
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 12 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Incomplete Abortion, run by Gynuity Health Projects at 2 sites in Burma.
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 12 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 12 Jun 2018. 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 Burma. 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?
Percentage of women with complete uterine evacuation with study medication alone. (time frame: 14 days). 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 12 Jun 2018.