Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

NCT ID: NCT02707653

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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

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Incomplete Abortion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Miso

Misoprostol 400 s/l

Group Type OTHER

Misoprostol

Intervention Type DRUG

400 mcg sublingual misoprostol

Interventions

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Misoprostol

400 mcg sublingual misoprostol

Intervention Type DRUG

Other Intervention Names

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cytotec

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Research, Lower Myanmar

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Woman's Hospital

Yangon, , Burma

Site Status

Thingyan Sanpya Hospital

Yangon, , Burma

Site Status

Countries

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Burma

Other Identifiers

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2001

Identifier Type: -

Identifier Source: org_study_id

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