NCT02707653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

February 19, 2016

Last Update Submit

June 8, 2018

Conditions

Incomplete Abortion

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (2)

  • Percentage of women experiencing side effects

    7-14 days

  • Level of self-reported acceptability of treatment

    7-14 days

Study Arms (1)

Miso

OTHER

Misoprostol 400 s/l

Drug: Misoprostol

Interventions

MisoprostolDRUG

400 mcg sublingual misoprostol

Also known as: cytotec
Miso

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \. Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Woman's Hospital

Yangon, Burma

Location

Thingyan Sanpya Hospital

Yangon, Burma

Location

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 14, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

BU(2)