Prevalence of Low Back and Pelvic Pain in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00883428
First received: April 16, 2009
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Pelvic Pain
Other: Set of questionnaires

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it

Resource links provided by NLM:


Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1158
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pergnant women
Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883428

Locations
Spain
Centro de Salud de Ciudad Jardín
Málaga, Andalucía, Spain, 29014
Centro de Salud El Limonar
Málaga, Andalucía, Spain, 29016
Centro de Salud de Andratx
Andraxt, Balearic Islands, Spain, 07150
Centro de Salud de Campos
Campos, Balearic Islands, Spain, 07630
Centro de Salud Lluchmajor - Mitjorn
Lluchmajor, Balearic Islands, Spain, 07620
Centro de Salud Son Rullán
Palma de Mallorca, Balearic Islands, Spain, 07008
Centro de Salud del Col dén Rabassa
Palma de Mallorca, Balearic Islands, Spain, 07007
Centro de Salud de La Vileta
Palma de Mallorca, Balearic Islands, Spain, 07000
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain, 07012
Centro de Salud de Valldargent
Palma de Mallorca, Balearic Islands, Spain, 07013
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Centro de Salud del Rafal Nou
Palma de Mallorca, Balearic Islands, Spain, 07008
Centro de Salud del Campo Redó
Palma de Mallorca, Balearic Islands, Spain, 07010
Centro de Salud de Son Pisá
Palma de Mallorca, Balearic Islands, Spain, 07011
Centro de Salud de Santa Catalina
Palma de Mallorca, Balearic Islands, Spain, 07013
Centro de Salud de Santa Ponsa
Santa Ponsa, Balearic Islands, Spain, 07180
Centro de Salud de Bembibre
Bembibre, León, Spain, 24300
Depto. de Enfermería y Fisioterapia, Universidad de León
Ponferrada, León, Spain, 24400
Centro de Salud Benita de Avila
Madrid, Spain, 28043
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Kovacs Foundation
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
  More Information

Publications:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00883428     History of Changes
Other Study ID Numbers: FK 28
Study First Received: April 16, 2009
Last Updated: March 11, 2014
Health Authority: Spain: Comité Etico de Investigación Clínica de la Fundación Kovacs
Spain: Comité Ético de Investigación Clínica de las Islas Baleares

Keywords provided by Kovacs Foundation:
low back pain
pelvic pain
pregnancy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014