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

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05403437
Collaborator
(none)
63
1
12.5
5.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of pain
  • Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests
  • Other: Evaluation of activity limitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
63 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Determining of painful areas [Baseline (Current)]

    Marking painful areas on the body chart

  2. 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).

  3. Application of PGP diagnostic tests [Baseline]

    Pelvic Girdle Pain diagnostic tests will be applied.

  4. 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

  1. Pelvic Girdle Questionnaire [Baseline]

    Activity limitation will be evaluated Pelvic Girdle Questionnaire

  2. Evaluation of Body Weight [Baseline]

    Measuring of the Body Weight

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ─░stanbul Medeniyet University ─░stanbul Turkey

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT05403437
Other Study ID Numbers:
  • 35 09/03/2022
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022