Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-08-31

Brief Summary

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The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

Detailed Description

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The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Conditions

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Catheter Placement and Perceived Pain

Keywords

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sonohysterography, catheter placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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cervical vs. uterine placement of balloon catheter

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.

Exclusion Criteria

* previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Lindheim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Department of Reproductive Endocrinology and Infertility

References

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Spieldoch RL, Winter TC, Schouweiler C, Ansay S, Evans MD, Lindheim SR. Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21. doi: 10.1097/01.AOG.0000295865.93719.3f.

Reference Type DERIVED

PMID: 18165388 (View on PubMed)

Other Identifiers

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H-2004-0066

Identifier Type: -

Identifier Source: org_study_id