Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation

NCT ID: NCT01829451

Last Updated: 2013-04-11

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.

Detailed Description

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Conditions

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Menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hyaluronic acid gel

Hyaluronic acid gel is placed into the uterus after endometrial ablation

Group Type EXPERIMENTAL

Hyaluronic acid gel

Intervention Type OTHER

Hyaluronic acid gel is placed into the uterus after endometrial ablation

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No hyaluronic acid gel

An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Hyaluronic acid gel

Hyaluronic acid gel is placed into the uterus after endometrial ablation

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Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* menorrhagia

Exclusion Criteria

* abnormal uterine cavity,
* abnormal endometrial biopsy
Minimum Eligible Age

35 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Uoulu

Identifier Type: -

Identifier Source: org_study_id

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