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

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

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

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
Pergnant women
Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.
A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.

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
24 months

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
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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.

Clinical Trials on Low Back Pain

Clinical Trials on Set of questionnaires

3
Subscribe