PRECIOUS: Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01731288

Collaborator

(none)

241

Enrollment

Location

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvodynia Provoked Vestibulodynia

Study Design

Study Type:

Observational

Actual Enrollment :

241 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
vulvodynia Women with vulvodynia
control Women without vulvar pain

Outcome Measures

Primary Outcome Measures

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
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.
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.
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.
Symptom management during pregnancy [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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