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CompletedNCT00883428Updated Mar 13, 2014

Prevalence of Low Back and Pelvic Pain in Pregnant Women

An observational study in Low Back Pain and Pelvic Pain, sponsored by Kovacs Foundation. Completed at 20 sites in Spain. Open to female participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-13.

Sponsored by Kovacs Foundation · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
1,158
Ages
18 Years to 48 Years
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Low Back Pain
  • Pelvic Pain

Keywords

  • low back pain
  • pelvic pain
  • pregnancy
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In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 1,158 is above the median of 100 across 483 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Kovacs Foundation is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Time perspective
Cross-sectional
Enrollment
1,158 participants (actual)

Groups and cohorts

  • 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

Interventions

  • OtherSet 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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What researchers measure

Primary outcomes

  1. The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.

    Time frame: 24 months

Secondary outcomes

  1. 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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Study locations

20 sites
  • 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
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References and documents

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. PubMed 2956698 ↗
  • 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. PubMed 8725930 ↗
  • 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. PubMed 8122500 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00883428
Lead sponsor
Kovacs Foundation
Responsible party
Francisco M. Kovacs (Director of Scientific Department, Kovacs Foundation, Kovacs Foundation) — Principal investigator
First posted
Apr 17, 2009
Start date
Jun 2009
Primary completion
Apr 2011
Completion
Jun 2011
Last update
Mar 13, 2014

Study contacts

Francisco M Kovacs, MD, PhD
study director · Kovacs Foundation, Palma de Mallorca, 07012, Spain
Betina Nishishinya, MD
principal investigator · Kovacs Foundation, Palma de Mallorca, 07012, Spain

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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