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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Women; Gestational Diabetes; Pelvic Girdle Pain
• Intervention / Treatment: Other: Evaluation of pain; Diagnostic test: Evaluation of pelvic girdle pain diagnostic tests; Other: Evaluation of activity limitation

• Study Type: Observational
• Enrollment (Anticipated): 63

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).; Diagnostic test: Evaluation of pelvic girdle pain diagnostic tests; Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.; Other: Evaluation of activity limitation; The Pelvic Girdle Questionnaire will be filled.
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; 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).; Diagnostic test: Evaluation of pelvic girdle pain diagnostic tests; Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.; Other: Evaluation of activity limitation; The Pelvic Girdle Questionnaire will be filled.
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; 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).; Diagnostic test: Evaluation of pelvic girdle pain diagnostic tests; Pelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS.

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): March 15, 2023
• Study Completion (ANTICIPATED): June 15, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (ACTUAL): June 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: pregnant women; gestational diabetes; pelvic girdle pain
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Neurologic Manifestations; Endocrine System Diseases; Musculoskeletal Pain; Pregnancy Complications; Pelvic Pain; Diabetes Mellitus; Pain; Diabetes, Gestational; Pelvic Girdle Pain
• Other Study ID Numbers: 35 09/03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No