Pregnant WomenNCT05403437
Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus
An observational study of Pregnant Women and Gestational Diabetes, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Gestational Diabetes, Pelvic Girdle Pain
- What is being tested?
- Evaluation of pain, Evaluation of pelvic girdle pain diagnostic tests and Evaluation of activity limitation
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 18 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with PGP and GDM Pregnant women with PGP but without GDM
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Pregnant Women, Gestational Diabetes, Pelvic Girdle Pain
- Being tested
- Evaluation of pain, Evaluation of pelvic girdle pain diagnostic tests, Evaluation of activity limitation
- Keywords
- pregnant women, pelvic girdle pain, gestational diabetes
- Medical subject headings
- Diabetes, Gestational, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of painOther
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 testsDiagnostic 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 limitationOther
The Pelvic Girdle Questionnaire will be filled.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Evaluation of pain; Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining of painful areas
Marking painful areas on the body chart
Measured: 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).
Measured: Baseline (Current)
Application of PGP diagnostic tests
Pelvic Girdle Pain diagnostic tests will be applied. No score defined for test.
Measured: 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).
Measured: Baseline
Secondary outcomes (3)
Pelvic Girdle Questionnaire
Activity limitation will be evaluated Pelvic Girdle Questionnaire
Measured: Baseline
Evaluation of Body Weight
Measuring of the Body Weight
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jun 2022
- Primary completion15 Sep 2024
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403437
- Sponsor's protocol ID
- 35 09/03/2022
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22718046Palsson 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.
PubMed 25540938Plows 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.
PubMed 30373146Eberhard-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.
PubMed 18763174Wuytack 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.
PubMed 31700607
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Gestational Diabetes Mellitus on Pelvic Girdle Pain Symptom Severity
- ClinicalTrials.gov ID
- NCT05403437
- Acronym / sponsor ID
- 35 09/03/2022
- Conditions
- Pregnant Women, Gestational Diabetes, Pelvic Girdle Pain
- Keywords
- pregnant women, pelvic girdle pain, gestational diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pregnant women with PGP and newly diagnosed with GDM | – | Other: Evaluation of pain, Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests, Other: Evaluation of activity limitationPregnant 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 |
| Group 2: Pregnant women with PGP and diagnosed with GDM | – | Other: Evaluation of pain, Diagnostic Test: Evaluation of pelvic girdle pain diagnostic tests, Other: Evaluation of activity limitationPregnant 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 |
| Group 3: Pregnant women with PGP | – | Other: Evaluation of pain, Diagnostic Test: Evaluation of pelvic girdle pain diagnostic testsPregnant women with PGP who were not diagnosed with GDM according to routine control examinations |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with PGP and GDM Pregnant women with PGP but without GDM
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of painPainful 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). | Other | 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 testsPelvic girdle pain diagnostic tests will be applied. The severity of the pain that occurs in positive tests will be evaluated with VAS. | Diagnostic test | 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 limitationThe Pelvic Girdle Questionnaire will be filled. | Other | Group 1: Pregnant women with PGP and newly diagnosed with GDM, Group 2: Pregnant women with PGP and diagnosed with GDM |
Primary outcome
Determining of painful areas
Time frame: Baseline (Current)
Marking painful areas on the body chart
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).
Application of PGP diagnostic tests
Time frame: Baseline
Pelvic Girdle Pain diagnostic tests will be applied. No score defined for test.
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).
3 secondary outcomes
Pelvic Girdle Questionnaire
Time frame: Baseline
Evaluation of Body Weight
Time frame: Baseline
Evaluation of Body Mass Index (BMI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Results publication: PubMed 22718046Aldabe 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.
- Results publication: PubMed 25540938Palsson 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.
- Results publication: PubMed 30373146Plows 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.
- Results publication: PubMed 18763174Eberhard-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.
- Results publication: PubMed 31700607Wuytack 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnant Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Gestational Diabetes, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining of painful areas (time frame: Baseline (Current)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403437, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.