Sublingual Misoprostol for the Treatment of Incomplete Ab... | NCT02707653

Studies
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

NCT02707653

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Jun 12, 2018Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Incomplete Abortion

Interventions

Misoprostol

Countries

Burma

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Feb 19, 2016

First Submission Date that Met QC Criteria

Mar 8, 2016

First Posted Date

Mar 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2018

Last Update Posted Date

Jun 12, 2018Actual

Name	Class
Department of Medical Research, Lower Myanmar	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Miso	Other	Misoprostol 400 s/l	Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	400 mcg sublingual misoprostol	Miso	cytotec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of women with complete uterine evacuation with study medication alone.		14 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of women experiencing side effects	occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.	7-14 days
Level of self-reported acceptability of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

1. Inability to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Central Woman's Hospital		Yangon			Burma
Thingyan Sanpya Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000027	Abortion, Incomplete

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided