Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Vulvodynia Clinical Trial

— PRECIOUS  

Official title:

Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731288
• Other study ID #: H11-00968
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: May 30, 2017
• Start date: March 2012
• Est. completion date: February 2016

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Locations

Country	Name	City	State
Canada	Diamond Health Care Centre, Vancouver Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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
Primary	Symptom management during pregnancy	We will assess how women manage their vulvodynia symptoms during pregnancy.	data is collected at a single time point
Primary	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	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