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NCT Number: NCT02707653

Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

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

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Key information

Conditions

Incomplete Abortion Abortion, Incomplete Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

12 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Central Woman's Hospital, Yangon, Burma

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About this study

This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

Misoprostol

Drug

400 mcg sublingual misoprostol

Other names: cytotec

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

    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.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Department of Medical Research, Lower Myanmar

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2016
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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