Platelet Rich Plasma Following Hysteroscopic Adhesolysis | NCT03881215

Studies
Platelet Rich Plasma Following Hysteroscopic Adhesolysis

NCT03881215

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

160Actual

Phase

Not Applicable

Conditions

Intra-uterine Adhesions

Interventions

Platelet Rich Plasma
intra-uterine balloon

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

Jan 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

Jan 1, 2016Actual

Primary Completion Date

Dec 10, 2019Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

Mar 16, 2019

First Submission Date that Met QC Criteria

Mar 16, 2019

First Posted Date

Mar 19, 2019Actual

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

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Platelet Rich Plasma	Experimental	PRP	Procedure: Platelet Rich Plasma Procedure: intra-uterine balloon
intra-uterine balloon	Active Comparator		Procedure: intra-uterine balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Plasma	Procedure	Platelet Rich Plasma	Platelet Rich Plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adhesion recurrence	recurrence of severe intra-uterine adhesions	3 months

Secondary Outcomes

Measure	Description	Time Frame
Days of menses	Number of days of menstrual cycle following operation	3 months
Amount of menses	Number of sanitary pads changed during each menstrual cycle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18-40 years
Grade III intra-uterine adhesions

Exclusion Criteria:

Age < 18 or > 40 years.
Hb < 11 g/dL, platelets < 150.000/mm3.
Patient taking anticoagulant.
Patient taking NSAID in the 10 days before procedure.
Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
Active cervical or uterine infection.
Undiagnosed genital bleeding.
pregnancy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 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
Ain Shams University Maternity Hospital		Cairo			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