Gestational Diabetes Clinical Trial
Official title:
Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity
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).
Status | Not yet recruiting |
Enrollment | 63 |
Est. completion date | June 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medeniyet University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Turkey,
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. Epub 2012 Jun 21. Review. — View 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. — View 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 he — View 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). pii: E3342. doi: 10.3390/ijms19113342. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determining of painful areas | Marking painful areas on the body chart | Baseline (Current) | |
Primary | Evaluation of pain | Pain will be evaluated with Visual Analog Scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain). | Baseline (Current) | |
Primary | Application of PGP diagnostic tests | Pelvic Girdle Pain diagnostic tests will be applied. | Baseline | |
Primary | Evaluation of PGP severity | The severity of the pain that occurs in positive tests will be evaluated with VAS. The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain). | Baseline | |
Secondary | Pelvic Girdle Questionnaire | Activity limitation will be evaluated Pelvic Girdle Questionnaire | Baseline | |
Secondary | Evaluation of Body Weight | Measuring of the Body Weight | Baseline | |
Secondary | Evaluation of Body Mass Index (BMI) | BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters. | Baseline |
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