Pain in Diagnostic Hysteroscopy

NCT ID: NCT01873391

Last Updated: 2014-02-06

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

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.

Detailed Description

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Conditions

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Pain in Diagnostic Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Normal saline

Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy.

Group Type ACTIVE_COMPARATOR

Diagnostic hysteroscopy

Intervention Type PROCEDURE

Carbon dioxide

Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy.

Group Type ACTIVE_COMPARATOR

Diagnostic hysteroscopy

Intervention Type PROCEDURE

Interventions

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Diagnostic hysteroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* female gender
* diagnostic hysteroscopy indication
* italian-speaking patients

Exclusion Criteria

* patients who had previously undergone a diagnostic hysteroscopy
* patients who had been previously undergone to cervical surgery
* ongoing pregnancy
* cervical carcinoma
* pelvic inflammatory disease
* excessive uterine bleeding
* performance of an endometrial biopsy during the procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sandro Gerli

OTHER

Sponsor Role lead

Responsible Party

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Sandro Gerli

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sandro Gerli, MD

Role: STUDY_DIRECTOR

University Of Perugia

Locations

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Arbor Vitae Endoscopic Centre

Rome, Italy, Italy

Site Status

Countries

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Italy

References

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Mazzon I, Favilli A, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial. Fertil Steril. 2014 Nov;102(5):1398-403. doi: 10.1016/j.fertnstert.2014.07.1249. Epub 2014 Sep 18.

Reference Type DERIVED
PMID: 25241369 (View on PubMed)

Other Identifiers

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co2 vs h2o

Identifier Type: -

Identifier Source: org_study_id

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