Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

NCT01731288 | Completed

• 1 other identifier: H11-00968
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia; Provoked Vestibulodynia

Keywords

pregnancy; childbirth; pain; vulvodynia; provoked vestibulodynia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Course of vulvodynia

  data is collected at a single time point

Study Arms (2)

vulvodynia

Women with vulvodynia

control

Women without vulvar pain

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)
• years of age or older
• fluent in English

You may not qualify if:

• younger than 19 years of age
• lack of fluency in English

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Diamond Health Care Centre, Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

• University of British Columbia Sexual Health Lab website

MeSH Terms

Conditions

Vulvodynia; Pain

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori A Brotto, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

CA (1)