Clinical trial NCT01731288: Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
Official title: Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvodynia
Provoked Vestibulodynia
Keywords: pregnancy
childbirth
pain
vulvodynia
provoked vestibulodynia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 241
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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1) Vulvar Pain Clinic (no longer active) located at the Women's Clinic, Willow Pavilion, Vancouver General Hospital; 2) Multidisciplinary Vulvodynia Program (MVP); or 3) BC Centre for Sexual Medicine

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rates
timeFrame: data is collected at a single time point
measure: Intentions to have children
timeFrame: data is collected at a single time point
measure: Fear of pregnancy/childbirth
timeFrame: data is collected at a single time point
measure: Difficulties becoming pregnant
timeFrame: data is collected at a single time point
measure: Pregnancy/delivery complications
timeFrame: data is collected at a single time point.
measure: Pregnancy/delivery methods
timeFrame: data is collected at a single time point
measure: Symptom management during pregnancy
timeFrame: data is collected at a single time point
measure: Change of pain symptoms during and after pregnancy
timeFrame: data is collected at a single time point
Secondary outcomes:
measure: Course of vulvodynia
timeFrame: data is collected at a single time point
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Diamond Health Care Centre, Vancouver Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: