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Platelet Rich Plasma Following Hysteroscopic Adhesolysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881215
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Condition or disease Intervention/treatment Phase
Intra-uterine Adhesions Procedure: Platelet Rich Plasma Procedure: intra-uterine balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Platelet Rich Plasma
PRP
Procedure: Platelet Rich Plasma
Platelet Rich Plasma

Procedure: intra-uterine balloon
intra-uterine balloon

Active Comparator: intra-uterine balloon Procedure: intra-uterine balloon
intra-uterine balloon




Primary Outcome Measures :
  1. Incidence of adhesion recurrence [ Time Frame: 3 months ]
    recurrence of severe intra-uterine adhesions


Secondary Outcome Measures :
  1. Days of menses [ Time Frame: 3 months ]
    Number of days of menstrual cycle following operation

  2. Amount of menses [ Time Frame: 3 months ]
    Number of sanitary pads changed during each menstrual cycle



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881215


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03881215    
Other Study ID Numbers: AS1811
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes