Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain (PRECIOUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01731288
First received: November 15, 2012
Last updated: January 29, 2014
Last verified: January 2014
  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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731288

Contacts
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

Locations
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         
Sponsors and Collaborators
University of British Columbia
Investigators
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: January 29, 2014
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 August 19, 2014