Back to resultsPlatelet Rich Plasma Following Hysteroscopic Adhesolysis
Primary Purpose
Intra-uterine Adhesions
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet Rich Plasma
intra-uterine balloon
Sponsored by
About this trial
This is an interventional prevention trial for Intra-uterine Adhesions
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.
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet Rich Plasma
intra-uterine balloon
Arm Description
PRP
Outcomes
Primary Outcome Measures
Incidence of adhesion recurrence
recurrence of severe intra-uterine adhesions
Secondary Outcome Measures
Days of menses
Number of days of menstrual cycle following operation
Amount of menses
Number of sanitary pads changed during each menstrual cycle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03881215
Brief Title
Platelet Rich Plasma Following Hysteroscopic Adhesolysis
Official Title
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-uterine Adhesions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm Description
PRP
Arm Title
intra-uterine balloon
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Platelet Rich Plasma
Intervention Type
Procedure
Intervention Name(s)
intra-uterine balloon
Intervention Description
intra-uterine balloon
Primary Outcome Measure Information:
Title
Incidence of adhesion recurrence
Description
recurrence of severe intra-uterine adhesions
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Days of menses
Description
Number of days of menstrual cycle following operation
Time Frame
3 months
Title
Amount of menses
Description
Number of sanitary pads changed during each menstrual cycle
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet Rich Plasma Following Hysteroscopic Adhesolysis
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