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CompletedNCT02707653Updated Jun 12, 2018

Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

An interventional study of Misoprostol in Incomplete Abortion, sponsored by Gynuity Health Projects. Completed at 2 sites in Myanmar. Open to female participants aged 12 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
12 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Incomplete Abortion

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03

In context

Abortion, Incomplete

24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.

This study's enrollment of 75 is below the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.

Browse Abortion, Incomplete studies →

Lead sponsor

Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Confirmed incomplete abortion
  2. No known to the study drug
  3. Uterine size no larger than 12 weeks at time of presentation for care
  4. No signs of severe infection, defined as at least two of the following:

    • foul smelling discharge,
    • fever > 38 degrees C, 100 degrees Fahrenheit
    • uterine tenderness.
  5. No hemodynamic disturbances (pulse >110/min and systolic bp \<100)
  6. General good health
  7. Agree to comply with study procedures including return for follow up visit
  8. Live or work within one hour from a study site
  9. Willing and able to sign consent forms

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    Miso

    Misoprostol 400 s/l

    Drug: Misoprostol

Interventions

  • 400 mcg sublingual misoprostol

    Also known as: cytotec

06

What researchers measure

Primary outcomes

  1. Percentage of women with complete uterine evacuation with study medication alone.

    Time frame: 14 days

Secondary outcomes

  1. Percentage of women experiencing side effects

    occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.

    Time frame: 7-14 days

  2. 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.

    Time frame: 7-14 days

07

Study locations

2 sites
  • Central Woman's Hospital
    Yangon, Myanmar
  • Thingyan Sanpya Hospital
    Yangon, Myanmar
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in Nov 2016, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2016
First posted
Mar 14, 2016
StartActual
Mar 2016
Primary completionActual
Nov 2016
CompletionActual
Nov 2016
Last update
Jun 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02707653
Collaborators
Department of Medical Research, Lower Myanmar
Responsible party
Sponsor
First posted
Mar 14, 2016
Start date
Mar 2016
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Jun 12, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Misoprostol

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