Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Determining of painful areas
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Determining of painful areas
时间窗: Baseline (Current)
Marking painful areas on the body chart
Evaluation of pain
时间窗: Baseline (Current)
Pain will be evaluated with Visual Analog Scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).
Application of PGP diagnostic tests
时间窗: Baseline
Pelvic Girdle Pain diagnostic tests will be applied. No score defined for test.
Evaluation of PGP severity
时间窗: Baseline
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).
次要结局
- Pelvic Girdle Questionnaire(Baseline)
- Evaluation of Body Weight(Baseline)
- Evaluation of Body Mass Index (BMI)(Baseline)