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

Completed

• Conditions: Pelvic Girdle Pain; Pregnant Women; Gestational Diabetes
• Interventions: Other: Evaluation of pain; Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests; Other: Evaluation of activity limitation

• Registration Number: NCT05403437
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-05-31
• Study Start: 2022-06-01
• Study First Posted: 2022-06-03
• Primary Completion: 2024-09-15
• Study Completion: 2025-02-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Pregnant women with PGP and diagnosed with GDM	Evaluation of pain	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
Group 2: Pregnant women with PGP and diagnosed with GDM	Evaluation of pelvic girdle pain diagnostic tests	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
Group 3: Pregnant women with PGP	Evaluation of pain	Pregnant women with PGP who were not diagnosed with GDM according to routine control examinations
Group 1: Pregnant women with PGP and newly diagnosed with GDM	Evaluation of pelvic girdle pain diagnostic tests	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
Group 1: Pregnant women with PGP and newly diagnosed with GDM	Evaluation of activity limitation	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
Group 2: Pregnant women with PGP and diagnosed with GDM	Evaluation of activity limitation	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
Group 1: Pregnant women with PGP and newly diagnosed with GDM	Evaluation of pain	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
Group 3: Pregnant women with PGP	Evaluation of pelvic girdle pain diagnostic tests	Pregnant women with PGP who were not diagnosed with GDM according to routine control examinations

Primary Outcome Measures

Name	Time	Method
Determining of painful areas	Baseline (Current)	Marking painful areas on the body chart
Evaluation of pain	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	Baseline	Pelvic Girdle Pain diagnostic tests will be applied. No score defined for test.
Evaluation of PGP severity	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).

Secondary Outcome Measures

Name	Time	Method
Pelvic Girdle Questionnaire	Baseline	Activity limitation will be evaluated Pelvic Girdle Questionnaire
Evaluation of Body Weight	Baseline	Measuring of the Body Weight
Evaluation of Body Mass Index (BMI)	Baseline	BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Trial Locations

Locations (1)

İstanbul Medeniyet University; 🇹🇷 İstanbul, Turkey