We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731288
First Posted: November 21, 2012
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
  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: Observational Model: Other
Time Perspective: Retrospective
Official Title: Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Resource links provided by NLM:


Further study details as provided by Lori Brotto, University of British Columbia:

Primary Outcome Measures:
  • Pregnancy Rates [ Time Frame: data is collected at a single time point ]
    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 ]
    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 ]
    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 ]
    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. ]
    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 ]
    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 ]
    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 ]
    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 ]
    We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.


Enrollment: 241
Study Start Date: March 2012
Study Completion Date: February 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
vulvodynia
Women with vulvodynia
control
Women without vulvar pain

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731288


Locations
Canada, British Columbia
Diamond Health Care Centre, Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Lori A Brotto, PhD University of British Columbia
  More Information

Responsible Party: Lori Brotto, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01731288     History of Changes
Other Study ID Numbers: H11-00968
First Submitted: November 15, 2012
First Posted: November 21, 2012
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Lori Brotto, University of British Columbia:
pregnancy
childbirth
pain
vulvodynia
provoked vestibulodynia

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis