- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883428
Prevalence of Low Back and Pelvic Pain in Pregnant Women
March 11, 2014 updated by: Francisco M. Kovacs, Kovacs Foundation
Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it
The purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women.
The results should allow for the identification of factors associated with a greater risk of having it during pregnancy.
Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Validated methods were used to gather data on the prevalence of LBP, LP and PGP, anthropometric and socio-demographic characteristics, history of LBP, obstetrical history, physical activity before and during pregnancy, mattress and sleep characteristics, disability, anxiety, and depression.
Separate multiple logistic regression models were developed to identify the variables associated with LBP, LP and PGP.
Study Type
Observational
Enrollment (Actual)
1158
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz
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Madrid, Spain, 28043
- Centro de Salud Benita de Ávila
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Andalucía
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Málaga, Andalucía, Spain, 29014
- Centro de Salud de Ciudad Jardín
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Málaga, Andalucía, Spain, 29016
- Centro de Salud El Limonar
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Balearic Islands
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Andraxt, Balearic Islands, Spain, 07150
- Centro de Salud de Andratx
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Campos, Balearic Islands, Spain, 07630
- Centro de Salud de Campos
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Lluchmajor, Balearic Islands, Spain, 07620
- Centro de Salud Lluchmajor - Mitjorn
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Palma de Mallorca, Balearic Islands, Spain, 07012
- Kovacs Foundation
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Palma de Mallorca, Balearic Islands, Spain, 07000
- Centro de Salud de La Vileta
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Palma de Mallorca, Balearic Islands, Spain, 07007
- Centro de Salud del Col dén Rabassa
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Palma de Mallorca, Balearic Islands, Spain, 07008
- Centro de Salud del Rafal Nou
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Palma de Mallorca, Balearic Islands, Spain, 07008
- Centro de Salud Son Rullán
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Palma de Mallorca, Balearic Islands, Spain, 07010
- Centro de Salud del Campo Redó
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Palma de Mallorca, Balearic Islands, Spain, 07011
- Centro de Salud de Son Pisá
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Palma de Mallorca, Balearic Islands, Spain, 07012
- Hospital Son Dureta
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Palma de Mallorca, Balearic Islands, Spain, 07013
- Centro de Salud de Santa Catalina
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Palma de Mallorca, Balearic Islands, Spain, 07013
- Centro de Salud de Valldargent
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Santa Ponsa, Balearic Islands, Spain, 07180
- Centro de Salud de Santa Ponsa
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León
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Bembibre, León, Spain, 24300
- Centro de Salud de Bembibre
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Ponferrada, León, Spain, 24400
- Depto. de Enfermería y Fisioterapia, Universidad de León
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).
Description
Inclusion Criteria:
- A pregnancy of 28 weeks or more
- Able to understand, read and write Spanish
- Seen at participating health centers or hospitals in the study
- Signs informed consent form
Exclusion Criteria:
- Refusal to participate in the study
- Being under 18 years of age or legally mentally incapacitated
- Having a diagnosis of illnesses that can cause back pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Pergnant women
Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.
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A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.
Time Frame: 24 months
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women.
Time Frame: 30 months
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30 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Francisco M Kovacs, MD, PhD, Kovacs Foundation, Palma de Mallorca, 07012, Spain
- Principal Investigator: Betina Nishishinya, MD, Kovacs Foundation, Palma de Mallorca, 07012, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fast A, Shapiro D, Ducommun EJ, Friedmann LW, Bouklas T, Floman Y. Low-back pain in pregnancy. Spine (Phila Pa 1976). 1987 May;12(4):368-71. doi: 10.1097/00007632-198705000-00011.
- Mens JM, Vleeming A, Stoeckart R, Stam HJ, Snijders CJ. Understanding peripartum pelvic pain. Implications of a patient survey. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1363-9; discussion 1369-70. doi: 10.1097/00007632-199606010-00017.
- Orvieto R, Achiron A, Ben-Rafael Z, Gelernter I, Achiron R. Low-back pain of pregnancy. Acta Obstet Gynecol Scand. 1994 Mar;73(3):209-14. doi: 10.3109/00016349409023441.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 16, 2009
First Submitted That Met QC Criteria
April 16, 2009
First Posted (Estimate)
April 17, 2009
Study Record Updates
Last Update Posted (Estimate)
March 13, 2014
Last Update Submitted That Met QC Criteria
March 11, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FK 28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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