Clinical trial NCT00883428: Prevalence of Low Back and Pelvic Pain in Pregnant Women
Official title: Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Pelvic Pain
Keywords: low back pain
pelvic pain
pregnancy
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 1158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).

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.

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 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

Primary outcomes:
measure: The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.
timeFrame: 24 months
Secondary outcomes:
measure: The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women.
timeFrame: 30 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Centro de Salud de Ciudad Jardín
state: Andalucía
city: Málaga
country: Spain
facility: Centro de Salud El Limonar
state: Andalucía
city: Andraxt
country: Spain
facility: Centro de Salud de Andratx
state: Balearic Islands
city: Campos
country: Spain
facility: Centro de Salud de Campos
state: Balearic Islands
city: Lluchmajor
country: Spain
facility: Centro de Salud Lluchmajor - Mitjorn
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud de La Vileta
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud del Col dén Rabassa
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud del Rafal Nou
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud Son Rullán
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud del Campo Redó
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud de Son Pisá
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud de Santa Catalina
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Centro de Salud de Valldargent
state: Balearic Islands
city: Santa Ponsa
country: Spain
facility: Centro de Salud de Santa Ponsa
state: Balearic Islands
city: Bembibre
country: Spain
facility: Centro de Salud de Bembibre
state: León
city: Ponferrada
country: Spain
facility: Depto. de Enfermería y Fisioterapia, Universidad de León
state: León
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Centro de Salud Benita de Avila
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Betina Nishishinya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.