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

NCT05403437 | Completed

• 1 other identifier: 35 09/03/2022
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnant Women; Gestational Diabetes; Pelvic Girdle Pain

Keywords

pregnant women; pelvic girdle pain; gestational diabetes

Outcome Measures

Primary Outcomes (4)

• 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. No score defined for test.

  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 Outcomes (3)

• Pelvic Girdle Questionnaire

  Baseline

• Evaluation of Body Weight

  Baseline

• Evaluation of Body Mass Index (BMI)

  Baseline

Study Arms (3)

Group 1: Pregnant women with PGP and newly diagnosed with GDM

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; Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests; Other: Evaluation of activity limitation

Group 2: Pregnant women with PGP and diagnosed with GDM

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; Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests; Other: Evaluation of activity limitation

Group 3: Pregnant women with PGP

Pregnant women with PGP who were not diagnosed with GDM according to routine control examinations

Other: Evaluation of pain; Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests

Interventions

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).

Group 1: Pregnant women with PGP and newly diagnosed with GDM; Group 2: Pregnant women with PGP and diagnosed with GDM; Group 3: Pregnant women with PGP

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.

Group 1: Pregnant women with PGP and newly diagnosed with GDM; Group 2: Pregnant women with PGP and diagnosed with GDM; Group 3: Pregnant women with PGP

Evaluation of activity limitation OTHER

The Pelvic Girdle Questionnaire will be filled.

Group 1: Pregnant women with PGP and newly diagnosed with GDM; Group 2: Pregnant women with PGP and diagnosed with GDM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women with PGP and GDM Pregnant women with PGP but without GDM

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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. doi: 10.1007/s00586-012-2401-1. Epub 2012 Jun 21.

  PMID: 22718046 RESULT

• 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 health. J Pain. 2015 Mar;16(3):270-82. doi: 10.1016/j.jpain.2014.12.002. Epub 2014 Dec 23.

  PMID: 25540938 RESULT

• 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):3342. doi: 10.3390/ijms19113342.

  PMID: 30373146 RESULT

• 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.

  PMID: 18763174 RESULT

• 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.

  PMID: 31700607 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: June 3, 2022
• Study Start: June 1, 2022
• Primary Completion: September 15, 2024
• Study Completion: February 18, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

TU (1)