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: Completed
• Conditions: Vulvodynia; Provoked Vestibulodynia

• Study Type: Observational
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Diamond Health Care Centre, Vancouver Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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1) Vulvar Pain Clinic (no longer active) located at the Women's Clinic, Willow Pavilion, Vancouver General Hospital; 2) Multidisciplinary Vulvodynia Program (MVP); or 3) BC Centre for Sexual Medicine

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
vulvodynia; Women with vulvodynia
control; Women without vulvar pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Course of vulvodynia	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: University of British Columbia

Publications and helpful links

Helpful Links

• University of British Columbia Sexual Health Lab website

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pain; pregnancy; childbirth; provoked vestibulodynia; vulvodynia
• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvitis; Vulvodynia; Vulvar Vestibulitis
• Other Study ID Numbers: H11-00968