- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731288
Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain (PRECIOUS)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Diamond Health Care Centre, Vancouver Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The control group consists of a community sample. The vulvodynia group consists of women who have been diagnosed with vulvodynia/provoked vestibulodynia and who have been assessed and/or treated at 1 of 3 tertiary clinics:
1) Vulvar Pain Clinic (no longer active) located at the Women's Clinic, Willow Pavilion, Vancouver General Hospital; 2) Multidisciplinary Vulvodynia Program (MVP); or 3) BC Centre for Sexual Medicine
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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vulvodynia
Women with vulvodynia
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control
Women without vulvar pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy Rates
Time Frame: data is collected at a single time point
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We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain
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data is collected at a single time point
|
Intentions to have children
Time Frame: data is collected at a single time point
|
We will assess how many women with vulvodynia wish to have children in their lifetime.
|
data is collected at a single time point
|
Fear of pregnancy/childbirth
Time Frame: data is collected at a single time point
|
We will assess if women with vulvodynia report higher levels of fear about pregnancy and childbirth in comparison to women without such pain.
|
data is collected at a single time point
|
Difficulties becoming pregnant
Time Frame: data is collected at a single time point
|
We will assess if women with vulvodynia experience more difficulties becoming pregnant in comparison to women without such pain.
|
data is collected at a single time point
|
Pregnancy/delivery complications
Time Frame: data is collected at a single time point.
|
We will assess if women with vulvodynia experience more complications during pregnancy and delivery in comparison to women without such pain.
|
data is collected at a single time point.
|
Pregnancy/delivery methods
Time Frame: data is collected at a single time point
|
We will assess what methods women with vulvodynia use to become pregnant and deliver.
|
data is collected at a single time point
|
Symptom management during pregnancy
Time Frame: data is collected at a single time point
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We will assess how women manage their vulvodynia symptoms during pregnancy.
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data is collected at a single time point
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Change of pain symptoms during and after pregnancy
Time Frame: data is collected at a single time point
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We will assess if vulvodynia-related pain symptoms change during and after pregnancy.
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data is collected at a single time point
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Course of vulvodynia
Time Frame: data is collected at a single time point
|
We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.
|
data is collected at a single time point
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11-00968
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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