Prevalence of Low Back and Pelvic Pain in Pregnant Women
This study has been completed.
Sponsor:
Kovacs Foundation
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00883428
First received: April 16, 2009
Last updated: June 26, 2011
Last verified: June 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 16, 2009 | ||||||||
| Last Updated Date | June 26, 2011 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy. [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00883428 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women. [ Time Frame: 30 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevalence of Low Back and Pelvic Pain in Pregnant Women | ||||||||
| Official Title ICMJE | Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy). |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Set of questionnaires
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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| Study Group/Cohort (s) | Pergnant women
Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.
Intervention: Other: Set of questionnaires |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 1158 | ||||||||
| Completion Date | June 2011 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 48 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Spain | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00883428 | ||||||||
| Other Study ID Numbers ICMJE | FK 28 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. Francisco M. Kovacs, Kovacs Foundation | ||||||||
| Study Sponsor ICMJE | Kovacs Foundation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kovacs Foundation | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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