VulvodyniaPRECIOUSNCT01731288
Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
An observational study of Vulvodynia and Provoked Vestibulodynia, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvodynia, Provoked Vestibulodynia
- How many people
- 241 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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vestibulodynia and who have been assessed and/or treated at 1 of 3 tertiary clinics: 1) Vulvar Pain Clinic (no longer active) located at the Women's Clinic, Willow Pavilion, Vancouver General Hospital; 2) Multidisciplinary Vulvodynia Program (MVP); or 3) BC Centre for Sexual Medicine
Who may be able to join
- 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
Who cannot join
- younger than 19 years of age
- lack of fluency in English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Diamond Health Care Centre, Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
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
- Medical subject headings
- Vulvodynia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vulvodynia | Women with vulvodynia | |
| control | Women without vulvar pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rates
We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: data is collected at a single time point
Symptom management during pregnancy
We will assess how women manage their vulvodynia symptoms during pregnancy.
Measured: 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.
Measured: data is collected at a single time point
Secondary outcomes (1)
Course of vulvodynia
We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.
Measured: data is collected at a single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731288
- Sponsor's protocol ID
- H11-00968
- Acronym
- PRECIOUS
- Status last verified
- May 2017
- First submitted
- 15 Nov 2012
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain
- ClinicalTrials.gov ID
- NCT01731288
- Acronym / sponsor ID
- PRECIOUS / H11-00968
- Conditions
- Vulvodynia, Provoked Vestibulodynia
- Keywords
- pregnancy, childbirth, pain, vulvodynia, provoked vestibulodynia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vulvodynia | – | –Women with vulvodynia |
| control | – | –Women without vulvar pain |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- younger than 19 years of age
- lack of fluency in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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.
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.
1 secondary outcome
Course of vulvodynia
Time frame: data is collected at a single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- University of British Columbia Sexual Health Lab websiteLink provided by the sponsor.
Related trials for Vulvodynia
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A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
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Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
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A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia and Provoked Vestibulodynia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rates (time frame: data is collected at a single time point). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.