Clinical trial NCT05403437: Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus
Official title: Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Gestational Diabetes
Pelvic Girdle Pain
Keywords: pregnant women
pelvic girdle pain
gestational diabetes
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with PGP and GDM Pregnant women with PGP but without GDM

Brief summary: Pelvic girdle pain (PGP), which is a common musculoskeletal problem of pregnancy, and gestational diabetes mellitus (GDM), which is diagnosed at the end of the second trimester and at the beginning of the third trimester, occur in a parallel time period. The addition of hyperglycemia to the physiological changes in pregnancy stimulates a new series of cycles and contributes to inflammation, and it is predicted that the presence of GDM may trigger the pain intensity of PGP. Therefore, the aim of this study is to investigate the effect of GDM on PGP symptom severity (pain).


Eligibility criteria: Inclusion Criteria:

* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have been started.
* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have not been started
* Pregnant women (with PGP) who were not diagnosed with GDM in the 2nd and 3rd trimesters

Exclusion Criteria:

* Pre-pregnancy Diabetes Mellitus
* Presence of an orthopedic or neurological problem that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
* Presence of connective tissue disease
* Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity \>4 according to VAS) before pregnancy
* History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
* History of pelvic fracture

Primary outcomes:
measure: Determining of painful areas
timeFrame: Baseline (Current)
measure: Evaluation of pain
timeFrame: Baseline (Current)
measure: Application of PGP diagnostic tests
timeFrame: Baseline
measure: Evaluation of PGP severity
timeFrame: Baseline
Secondary outcomes:
measure: Pelvic Girdle Questionnaire
timeFrame: Baseline
measure: Evaluation of Body Weight
timeFrame: Baseline
measure: Evaluation of Body Mass Index (BMI)
timeFrame: Baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
citation: Aldabe D, Milosavljevic S, Bussey MD. Is pregnancy related pelvic girdle pain associated with altered kinematic, kinetic and motor control of the pelvis? A systematic review. Eur Spine J. 2012 Sep;21(9):1777-87. doi: 10.1007/s00586-012-2401-1. Epub 2012 Jun 21.
citation: Palsson TS, Beales D, Slater H, O'Sullivan P, Graven-Nielsen T. Pregnancy is characterized by widespread deep-tissue hypersensitivity independent of lumbopelvic pain intensity, a facilitated response to manual orthopedic tests, and poorer self-reported health. J Pain. 2015 Mar;16(3):270-82. doi: 10.1016/j.jpain.2014.12.002. Epub 2014 Dec 23.
citation: Plows JF, Stanley JL, Baker PN, Reynolds CM, Vickers MH. The Pathophysiology of Gestational Diabetes Mellitus. Int J Mol Sci. 2018 Oct 26;19(11):3342. doi: 10.3390/ijms19113342.
citation: Eberhard-Gran M, Eskild A. Diabetes mellitus and pelvic girdle syndrome in pregnancy--is there an association? Acta Obstet Gynecol Scand. 2008;87(10):1015-9. doi: 10.1080/00016340802345944.
citation: Wuytack F, O'Donovan M. Outcomes and outcomes measurements used in intervention studies of pelvic girdle pain and lumbopelvic pain: a systematic review. Chiropr Man Therap. 2019 Nov 5;27:62. doi: 10.1186/s12998-019-0279-2. eCollection 2019.