Platelet Rich Plasma Following Hysteroscopic Adhesolysis

NCT ID: NCT03881215

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-01-10

Brief Summary

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Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Detailed Description

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Conditions

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Intra-uterine Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Platelet Rich Plasma

PRP

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type PROCEDURE

Platelet Rich Plasma

intra-uterine balloon

Intervention Type PROCEDURE

intra-uterine balloon

intra-uterine balloon

Group Type ACTIVE_COMPARATOR

intra-uterine balloon

Intervention Type PROCEDURE

intra-uterine balloon

Interventions

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Platelet Rich Plasma

Platelet Rich Plasma

Intervention Type PROCEDURE

intra-uterine balloon

intra-uterine balloon

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1811

Identifier Type: -

Identifier Source: org_study_id

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