Prevalence of Low Back and Pelvic Pain in Pregnant Women
1 other identifier
observational
1,158
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 13, 2014
March 1, 2014
1.8 years
April 16, 2009
March 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.
24 months
Secondary Outcomes (1)
The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women.
30 months
Study Arms (1)
Pergnant women
Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.
Interventions
A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.
Eligibility Criteria
Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Centro de Salud de Ciudad Jardín
Málaga, Andalusia, 29014, Spain
Centro de Salud El Limonar
Málaga, Andalusia, 29016, Spain
Centro de Salud de Andratx
Andraxt, Balearic Islands, 07150, Spain
Centro de Salud de Campos
Campos, Balearic Islands, 07630, Spain
Centro de Salud Lluchmajor - Mitjorn
Lluchmajor, Balearic Islands, 07620, Spain
Centro de Salud de La Vileta
Palma de Mallorca, Balearic Islands, 07000, Spain
Centro de Salud del Col dén Rabassa
Palma de Mallorca, Balearic Islands, 07007, Spain
Centro de Salud del Rafal Nou
Palma de Mallorca, Balearic Islands, 07008, Spain
Centro de Salud Son Rullán
Palma de Mallorca, Balearic Islands, 07008, Spain
Centro de Salud del Campo Redó
Palma de Mallorca, Balearic Islands, 07010, Spain
Centro de Salud de Son Pisá
Palma de Mallorca, Balearic Islands, 07011, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07012, Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, 07012, Spain
Centro de Salud de Santa Catalina
Palma de Mallorca, Balearic Islands, 07013, Spain
Centro de Salud de Valldargent
Palma de Mallorca, Balearic Islands, 07013, Spain
Centro de Salud de Santa Ponsa
Santa Ponsa, Balearic Islands, 07180, Spain
Centro de Salud de Bembibre
Bembibre, León, 24300, Spain
Depto. de Enfermería y Fisioterapia, Universidad de León
Ponferrada, León, 24400, Spain
Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Centro de Salud Benita de Avila
Madrid, Madrid, 28043, Spain
Related Publications (3)
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.
PMID: 2956698BACKGROUNDMens 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.
PMID: 8725930BACKGROUNDOrvieto 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.
PMID: 8122500BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Scientific Department, Kovacs Foundation
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
March 13, 2014
Record last verified: 2014-03