Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
PRECIOUS
PRECIOUS
Sponsor study identifier
observational
241
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 15, 2012
Actual (reported)November 21, 2012
Actual (reported)August 2015
Actual (reported)February 2016
Actual (reported)Pregnancy Rates
We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain
data is collected at a single time point
Intentions to have children
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
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
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
Course of vulvodynia
data is collected at a single time point
Women with vulvodynia
Women without vulvar pain
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
Diamond Health Care Centre, Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Lori A Brotto, PhD
University of British Columbia
241 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Pregnancy/delivery complications
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
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
We will assess how women manage their vulvodynia symptoms during pregnancy.
data is collected at a single time point
Change of pain symptoms during and after pregnancy
We will assess if vulvodynia-related pain symptoms change during and after pregnancy.
data is collected at a single time point
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
June 1, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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