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Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

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ClinicalTrials.gov Identifier: NCT02707653
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Department of Medical Research, Lower Myanmar
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

Condition or disease Intervention/treatment Phase
Incomplete Abortion Drug: Misoprostol Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Miso
Misoprostol 400 s/l
Drug: Misoprostol
400 mcg sublingual misoprostol
Other Name: cytotec




Primary Outcome Measures :
  1. Percentage of women with complete uterine evacuation with study medication alone. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Percentage of women experiencing side effects [ Time Frame: 7-14 days ]
    occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.

  2. Level of self-reported acceptability of treatment [ Time Frame: 7-14 days ]
    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.



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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Confirmed incomplete abortion
  2. No known contraindications 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:

1. Inability to provide informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707653


Locations
Myanmar
Central Woman's Hospital
Yangon, Myanmar
Thingyan Sanpya Hospital
Yangon, Myanmar
Sponsors and Collaborators
Gynuity Health Projects
Department of Medical Research, Lower Myanmar

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02707653     History of Changes
Other Study ID Numbers: 2001
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics