Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

NCT ID: NCT01731288

Last Updated: 2017-06-01

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

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-02-29

Brief Summary

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The main purpose of this study is to assess conception, pregnancy, childbirth, and pain experiences among women who have been diagnosed with vulvodynia. Specifically, this study aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3) potential difficulties experienced while attempting to become pregnant and during pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.

Very little research has examined pregnancy/childbirth experiences among women with vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation that will provide descriptive information regarding many of the proposed research questions. Based on the clinical experience of the investigators, it is expected that women with vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and childbirth in comparison to women without such pain. It is also expected that women with vulvodynia will report more difficulties becoming pregnant as compared to women without such pain, and that women with vulvodynia will report more elective nonvaginal births in comparison to vaginal births.

Detailed Description

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Conditions

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Vulvodynia Provoked Vestibulodynia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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vulvodynia

Women with vulvodynia

No interventions assigned to this group

control

Women without vulvar pain

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* previous diagnosis of vulvodynia from a physician (women with vulvodynia only)
* assessed and/or treated at one of 3 clinics (women with vulvodynia only)
* free from chronic vulvar pain and pain with sexual intercourse in their lifetime (control women only)
* 19 years of age or older
* fluent in English

Exclusion Criteria

* younger than 19 years of age
* lack of fluency in English
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Lori Brotto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lori A Brotto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Diamond Health Care Centre, Vancouver Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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http://www.obgyn.ubc.ca/SexualHealth/

University of British Columbia Sexual Health Lab website

Other Identifiers

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H11-00968

Identifier Type: -

Identifier Source: org_study_id

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