Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain (PRECIOUS)
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Purpose
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.
| Condition |
|---|
|
Vulvodynia Provoked Vestibulodynia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain |
- Pregnancy Rates [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain
- Intentions to have children [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess how many women with vulvodynia wish to have children in their lifetime.
- Fear of pregnancy/childbirth [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess if women with vulvodynia report higher levels of fear about pregnancy and childbirth in comparison to women without such pain.
- Difficulties becoming pregnant [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess if women with vulvodynia experience more difficulties becoming pregnant in comparison to women without such pain.
- Pregnancy/delivery complications [ Time Frame: data is collected at a single time point. ] [ Designated as safety issue: No ]We will assess if women with vulvodynia experience more complications during pregnancy and delivery in comparison to women without such pain.
- Pregnancy/delivery methods [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess what methods women with vulvodynia use to become pregnant and deliver.
- Symptom management during pregnancy [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess how women manage their vulvodynia symptoms during pregnancy.
- Change of pain symptoms during and after pregnancy [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess if vulvodynia-related pain symptoms change during and after pregnancy.
- Course of vulvodynia [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.
| Estimated Enrollment: | 210 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
vulvodynia
Women with vulvodynia
|
|
control
Women without vulvar pain
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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
Contacts and Locations| Contact: Kelly B Smith, PhD | 604-875-4111 ext 68901 | kelly.smith@vch.ca |
| Contact: Lori A Brotto, PhD | 604-875-4111 ext 68898 | lori.brotto@vch.ca |
| Canada, British Columbia | |
| Diamond Health Care Centre, Vancouver Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Kelly B Smith, PhD 604-875-4111 ext 68901 kelly.smith@vch.ca | |
| Contact: Lori A Brotto, PhD 604-875-4111 ext 68898 lori.brotto@vch.ca | |
| Principal Investigator: Lori A Brotto, PhD | |
| Principal Investigator: | Lori A Brotto, PhD | University of British Columbia |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01731288 History of Changes |
| Other Study ID Numbers: | H11-00968 |
| Study First Received: | November 15, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
pregnancy childbirth pain vulvodynia provoked vestibulodynia |
Additional relevant MeSH terms:
|
Vulvodynia Vulvar Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013