Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Completed

• Conditions: Vulvodynia; Provoked Vestibulodynia

• Registration Number: NCT01731288
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Primary Completion: 2015-08
• Study Completion: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 241

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom management during pregnancy	data is collected at a single time point	We will assess how women manage their vulvodynia symptoms during pregnancy.
Pregnancy Rates	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
Fear of pregnancy/childbirth	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	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	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.
Change of pain symptoms during and after pregnancy	data is collected at a single time point	We will assess if vulvodynia-related pain symptoms change during and after pregnancy.
Intentions to have children	data is collected at a single time point	We will assess how many women with vulvodynia wish to have children in their lifetime.
Pregnancy/delivery methods	data is collected at a single time point	We will assess what methods women with vulvodynia use to become pregnant and deliver.

Secondary Outcome Measures

Name	Time	Method
Course of vulvodynia	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.

Trial Locations

Locations (1)

Diamond Health Care Centre, Vancouver Hospital; 🇨🇦 Vancouver, British Columbia, Canada