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Clinical Trials/NCT01731288
NCT01731288
Completed
Not Applicable

Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

University of British Columbia1 site in 1 country241 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vulvodynia
Sponsor
University of British Columbia
Enrollment
241
Locations
1
Primary Endpoint
Fear of pregnancy/childbirth
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
February 2016
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lori Brotto

Principal Investigator

University of British Columbia

Eligibility 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

Outcomes

Primary Outcomes

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.

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.

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

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.

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.

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.

Secondary Outcomes

  • Course of vulvodynia(data is collected at a single time point)

Study Sites (1)

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