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Completed

NCT Number: NCT05403437

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

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).

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Key information

Conditions

Pregnant Women Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Pain Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Pelvic Girdle Pain Pelvic Pain Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of pain

Other

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).

Evaluation of pelvic girdle pain diagnostic tests

Diagnostic Test

Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.

Evaluation of activity limitation

Other

The Pelvic Girdle Questionnaire will be filled.

Primary outcomes

  1. Determining of painful areas

    Time frame: Baseline (Current)

    Marking painful areas on the body chart

  2. Evaluation of pain

    Time frame: 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).

  3. Application of PGP diagnostic tests

    Time frame: Baseline

    Pelvic Girdle Pain diagnostic tests will be applied. No score defined for test.

  4. Evaluation of PGP severity

    Time frame: 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 outcomes

  1. Pelvic Girdle Questionnaire

    Time frame: Baseline

    Activity limitation will be evaluated Pelvic Girdle Questionnaire

  2. Evaluation of Body Weight

    Time frame: Baseline

    Measuring of the Body Weight

  3. Evaluation of Body Mass Index (BMI)

    Time frame: Baseline

    BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 3, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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