Platelet Rich Plasma Following Hysteroscopic Adhesolysis

Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Study Overview

• Status: Completed
• Conditions: Intra-uterine Adhesions
• Intervention / Treatment: Procedure: Platelet Rich Plasma; Procedure: intra-uterine balloon

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 10, 2019
• Study Completion (ACTUAL): January 10, 2020

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 16, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: AS1811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No