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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population

NCT05488197

Gestational Diabetes

COMPLETED

Afamin in Gestational Diabetes Mellitus

NCT04054843

Gestational Diabetes Mellitus in Pregnancy

COMPLETED

Individualized Early Diagnosis and Treatment System of Gestational Diabetes Mellitus (GDM) Based on New Continuous Glucose Monitoring (CGM) Technology

NCT07276945

Gestational Diabetes

NOT_YET_RECRUITING

Stratification of Risk of Diabetes in Early Pregnancy

NCT03005600

Gestational Diabetes Mellitus

UNKNOWN

Gestational Diabetes: a Cohort Study

NCT03307486

Gestational Diabetes Diabetes, Gestational Diabetes Mellitus in Pregnancy +1 more

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Women Gestational Diabetes Pelvic Girdle Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Evaluation of pain

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Evaluation of pain

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Evaluation of pain

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

Evaluation of activity limitation

The Pelvic Girdle Questionnaire will be filled.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes