Pelvic Girdle PainNCT01787266
Symptoms and Function During and After Pregnancy
An observational study of Pelvic Girdle Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to: 1. describe degree of symptoms and disability during and after pregnancy 2. to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing 3. to examine the responsiveness of The Pelvic Girdle Questionnaire Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain
- How many people
- 800 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Dec 2014
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women in week 32 - 36
Who may be able to join
- Pregnancy week 32-36
- Understand and read/write a questionnaire in Norwegian or English
Who cannot join
- Not able to understand and fill in a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
- describe degree of symptoms and disability during and after pregnancy
- to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing
- to examine the responsiveness of The Pelvic Girdle Questionnaire
- Conditions
- Pelvic Girdle Pain
- Medical subject headings
- Pelvic Girdle 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 |
|---|---|---|
| 1 | pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pelvic girdle questionnaire
Measured: 10 weeks postpartum
Secondary outcomes (1)
Pain intensity, Numeric rating scale
Measured: 10 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britt Stuge, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787266
- Sponsor's protocol ID
- PGQ2013
- Other IDs
- 129/12-303.0
- Status last verified
- Apr 2018
- First submitted
- 31 Jan 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Function During and After Pregnancy
- ClinicalTrials.gov ID
- NCT01787266
- Acronym / sponsor ID
- PGQ2013
- Conditions
- Pelvic Girdle Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Feb 2013 (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 purpose of this study is to:
- describe degree of symptoms and disability during and after pregnancy
- to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing
- to examine the responsiveness of The Pelvic Girdle Questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –pregnant women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women in week 32 - 36
Key inclusion criteria (2 listed)
- Pregnancy week 32-36
- Understand and read/write a questionnaire in Norwegian or English
Key exclusion criteria (1 listed)
- Not able to understand and fill in a questionnaire
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
the pelvic girdle questionnaire
Time frame: 10 weeks postpartum
1 secondary outcome
Pain intensity, Numeric rating scale
Time frame: 10 weeks postpartum
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 6 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Girdle Pain, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 1 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 6 Apr 2018. 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 Norway. 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?
the pelvic girdle questionnaire (time frame: 10 weeks postpartum). 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 6 Apr 2018.