Sublingual Misoprostol in Decreasing Blood Loss Prior to... | NCT02709564

Studies
Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

NCT02709564

Sponsor

Assiut University

Status

Completed

Last Update Posted

May 7, 2020Actual

Enrollment

80Actual

Phase

Phase 3

Conditions

Blood Loss in Myomectomy

Interventions

Misoprostol 400 sublingual
placebo 400 sublingual

Countries

Egypt

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

May 2020

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

Dec 2016Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Feb 2020Actual

First Submitted Date

Mar 11, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 16, 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

May 6, 2020

Last Update Posted Date

May 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Placebo Comparator	400 mg placebo	Drug: placebo 400 sublingual
Group B	Active Comparator	400 microgram misoprostol	Drug: Misoprostol 400 sublingual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol 400 sublingual	Drug	patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery	Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean amount of intraoperative blood loss		intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Change of hemoglobin after surgery		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
Age ≥ 18 years and ≤ 50 years
Pre-operative hemoglobin >8 g/dl
Ability to understand and the willingness to sign a written informed consent.
Admissible medical/surgical history
Five or less symptomatic uterine myomas
All myomas are subserous or intramural.
Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

Patients who have had a prior abdominal myomectomy
Post-menopausal women
Patients with known bleeding/clotting disorders
Patients with a history of gynecologic malignancy
Hypertension.
Cardiac and Pulmonary diseases.
Obesity (body mass index > 30 kg/m2).
History of allergic reactions attributed to misoprostol
Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided