Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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).

Official Title
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Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity

Conditions
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Pregnant Women, Gestational Diabetes, Pelvic Girdle Pain

Intervention / Treatment
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* Other: Evaluation of pain
* Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests
* Other: Evaluation of activity limitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Pregnant women with PGP and newly diagnosed with GDM<br>Pregnant women with PGP who were newly diagnosed with Gestational Diabetes Mellitus (GDM) according to routine control examinations and whose treatment for diabetes was not started | Other: Evaluation of pain<br>* Painful areas will be marked on the body chart. The presence and severity of pelvic girdle pain will be determined by the Visual Analog Scale (VAS).<br>Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests<br>* Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.<br>Other: Evaluation of activity limitation<br>* The Pelvic Girdle Questionnaire will be filled.<br>|
| Group 2: Pregnant women with PGP and diagnosed with GDM<br>Pregnant women with PGP who were diagnosed with Gestational Diabetes Mellitus (GDM) according to routine control examinations and whose treatment has been already started for diabetes | Other: Evaluation of pain<br>* Painful areas will be marked on the body chart. The presence and severity of pelvic girdle pain will be determined by the Visual Analog Scale (VAS).<br>Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests<br>* Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.<br>Other: Evaluation of activity limitation<br>* The Pelvic Girdle Questionnaire will be filled.<br>|
| Group 3: Pregnant women with PGP<br>Pregnant women with PGP who were not diagnosed with GDM according to routine control examinations | Other: Evaluation of pain<br>* Painful areas will be marked on the body chart. The presence and severity of pelvic girdle pain will be determined by the Visual Analog Scale (VAS).<br>Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests<br>* Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining of painful areas | Marking painful areas on the body chart | Baseline (Current) | 
| 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) | 
| Application of PGP diagnostic tests | Pelvic Girdle Pain diagnostic tests will be applied. | Baseline | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Girdle Questionnaire | Activity limitation will be evaluated Pelvic Girdle Questionnaire | Baseline | 
| Evaluation of Body Weight | Measuring of the Body Weight | Baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant women, pelvic girdle pain, gestational diabetes