Gestational DiabetesNCT04769375
Pelvic Girdle Pain in Pregnant Women
An observational study of Gestational Diabetes and Pelvic Girdle Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Pelvic girdle pain and gestational diabetes mellitus are experienced in similar trimesters of pregnancy. The aim of this study is to examine the effect of gestational diabetes mellitus on the occurrence of pelvic girdle pain and the severity of symptoms of pelvic girdle pain in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes, Pelvic Girdle Pain, Pregnant Woman
- What is being tested?
- Evaluation of pain, Application of pelvic girdle pain tests and Application of pelvic girdle questionnaire
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 20 Aug 2021
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult
Study population: Pegnant women with gestational diabetes mellitus (first pregnancy) Pegnant women with gestational diabetes mellitus (second or third pregnancy) Pegnant women without gestational diabetes mellitus (first pregnancy) Pegnant women without gestational diabetes mellitus (second or third pregnancy)
Who may be able to join
- Pregnant women diagnosed with GDM in the 2nd and 3rd trimesters Pregnant women without GDM diagnosis in 2nd and 3rd trimester First pregnancy Second or third pregnancy 20-40 years old
Who cannot join
- Diabetes mellitus before pregnancy The presence of an orthopedic or neurological problem that may cause musculoskeletal disorder and biomechanical sequence deviations from normal Pre-pregnancy chronic lumbar-pelvic pain description History of spine, pelvis or lower extremity surgery or fracture in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Gestational Diabetes Mellitus on the Pelvic Girdle Pain and Symptom Severity in Pregnant Women
Pelvic girdle pain and gestational diabetes mellitus are experienced in similar trimesters of pregnancy. The aim of this study is to examine the effect of gestational diabetes mellitus on the occurrence of pelvic girdle pain and the severity of symptoms of pelvic girdle pain in pregnant women.
- Conditions
- Gestational Diabetes, Pelvic Girdle Pain, Pregnant Woman
- Being tested
- Evaluation of pain, Application of pelvic girdle pain tests, Application of pelvic girdle questionnaire
- Keywords
- gestational diabetes mellitus, pregnancy pelvic girdle pain
- 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
The presence of pain localization pelvic girdle pain will be questioned in the body chart. Inaddition to this, the level of the pelvic girdle pain will be evaluated by visual analog scale.
Application of pelvic girdle pain testsOther
The tests will be applied sequentially to investigate the presence and severity of the pain (Tests: Posterior Pelvic Pain Provocation, Patriarch FABER, Long Dorsal Sacroiliac Ligament Pain Provocation, Simpsis Palpation, Modified Trendelenburg and Active Straight Leg Raise)
Application of pelvic girdle questionnaireOther
Pelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pregnant women diagnosed with GDM (first pregnancy) | This group will consist of women with gestational diabetes mellitus according to routine control tests in their first pregnancy. Receives: Other: Evaluation of pain; Other: Application of pelvic girdle pain tests; Other: Application of pelvic girdle questionnaire | |
| Group 2:Pregnant women diagnosed with GDM (2nd or 3rd pregnancy) | This group will consist of women with gestational diabetes mellitus according to routine control tests in their second or third pregnancy. Receives: Other: Evaluation of pain; Other: Application of pelvic girdle pain tests; Other: Application of pelvic girdle questionnaire | |
| Group 3: Healthy pregnant women (first pregnancy) | This group will consist of women who do not have gestational diabetes mellitus according to routine control tests in their first pregnancy. Receives: Other: Evaluation of pain; Other: Application of pelvic girdle pain tests; Other: Application of pelvic girdle questionnaire | |
| Group 4:Healthy pregnant women (2nd or 3rd pregnancy) | This group will consist of women who do not have gestational diabetes mellitus according to routine control tests in their second or third pregnancy. Receives: Other: Evaluation of pain; Other: Application of pelvic girdle pain tests; Other: Application of pelvic girdle questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain
Measuring of the presence of pain and severity level of pain with body chart and vısual analog scale
Measured: Baseline
Evaluation of test of pelvic girdle
Measuring of the presence of pain and severity level of pain with pelvic girdle provocation and palpation tests
Measured: Baseline
Evaluation of pelvic girdle questionnaire
Measuring of the pelvic girdle questionnaire (PGQ) in pregnant women with pelvic girdle pain
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- 200 participants (actual)
- Target duration
- 1 Day
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
- NCT04769375
- Sponsor's protocol ID
- 31
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
PubMed 18259783Eberhard-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 18763174Eivazi M, Abadi L. Low back pain in diabetes mellitus and importance of preventive approach. Health Promot Perspect. 2012 Jul 1;2(1):80-8. doi: 10.5681/hpp.2012.010. eCollection 2012.
PubMed 24688921Plows 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 30373146Wuytack 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 31700607Stuge B, Garratt A, Krogstad Jenssen H, Grotle M. The pelvic girdle questionnaire: a condition-specific instrument for assessing activity limitations and symptoms in people with pelvic girdle pain. Phys Ther. 2011 Jul;91(7):1096-108. doi: 10.2522/ptj.20100357. Epub 2011 May 19.
PubMed 21596959Palsson 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 25540938Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012 May;96(2):135-40. doi: 10.1016/j.diabres.2011.12.022. Epub 2012 Jan 12.
PubMed 22244365Martins RF, Pinto e Silva JL. Treatment of pregnancy-related lumbar and pelvic girdle pain by the yoga method: a randomized controlled study. J Altern Complement Med. 2014 Jan;20(1):24-31. doi: 10.1089/acm.2012.0715. Epub 2013 Mar 18.
PubMed 23506189
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Gestational Diabetes Mellitus on the Pelvic Girdle Pain and Symptom Severity in Pregnant Women
- ClinicalTrials.gov ID
- NCT04769375
- Acronym / sponsor ID
- 31
- Conditions
- Gestational Diabetes, Pelvic Girdle Pain, Pregnant Woman
- Keywords
- gestational diabetes mellitus, pregnancy pelvic girdle pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 24 Feb 2021 (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 and gestational diabetes mellitus are experienced in similar trimesters of pregnancy. The aim of this study is to examine the effect of gestational diabetes mellitus on the occurrence of pelvic girdle pain and the severity of symptoms of pelvic girdle pain in pregnant women.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pregnant women diagnosed with GDM (first pregnancy) | – | Other: Evaluation of pain, Other: Application of pelvic girdle pain tests, Other: Application of pelvic girdle questionnaireThis group will consist of women with gestational diabetes mellitus according to routine control tests in their first pregnancy. |
| Group 2:Pregnant women diagnosed with GDM (2nd or 3rd pregnancy) | – | Other: Evaluation of pain, Other: Application of pelvic girdle pain tests, Other: Application of pelvic girdle questionnaireThis group will consist of women with gestational diabetes mellitus according to routine control tests in their second or third pregnancy. |
| Group 3: Healthy pregnant women (first pregnancy) | – | Other: Evaluation of pain, Other: Application of pelvic girdle pain tests, Other: Application of pelvic girdle questionnaireThis group will consist of women who do not have gestational diabetes mellitus according to routine control tests in their first pregnancy. |
| Group 4:Healthy pregnant women (2nd or 3rd pregnancy) | – | Other: Evaluation of pain, Other: Application of pelvic girdle pain tests, Other: Application of pelvic girdle questionnaireThis group will consist of women who do not have gestational diabetes mellitus according to routine control tests in their second or third pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pegnant women with gestational diabetes mellitus (first pregnancy) Pegnant women with gestational diabetes mellitus (second or third pregnancy) Pegnant women without gestational diabetes mellitus (first pregnancy) Pegnant women without gestational diabetes mellitus (second or third pregnancy)
Key inclusion criteria (1 listed)
- Pregnant women diagnosed with GDM in the 2nd and 3rd trimesters Pregnant women without GDM diagnosis in 2nd and 3rd trimester First pregnancy Second or third pregnancy 20-40 years old
Key exclusion criteria (1 listed)
- Diabetes mellitus before pregnancy The presence of an orthopedic or neurological problem that may cause musculoskeletal disorder and biomechanical sequence deviations from normal Pre-pregnancy chronic lumbar-pelvic pain description 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 painThe presence of pain localization pelvic girdle pain will be questioned in the body chart. Inaddition to this, the level of the pelvic girdle pain will be evaluated by visual analog scale. | Other | Group 1: Pregnant women diagnosed with GDM (first pregnancy), Group 2:Pregnant women diagnosed with GDM (2nd or 3rd pregnancy), Group 3: Healthy pregnant women (first pregnancy), Group 4:Healthy pregnant women (2nd or 3rd pregnancy) |
| Application of pelvic girdle pain testsThe tests will be applied sequentially to investigate the presence and severity of the pain (Tests: Posterior Pelvic Pain Provocation, Patriarch FABER, Long Dorsal Sacroiliac Ligament Pain Provocation, Simpsis Palpation, Modified Trendelenburg and Active Straight Leg Raise) | Other | Group 1: Pregnant women diagnosed with GDM (first pregnancy), Group 2:Pregnant women diagnosed with GDM (2nd or 3rd pregnancy), Group 3: Healthy pregnant women (first pregnancy), Group 4:Healthy pregnant women (2nd or 3rd pregnancy) |
| Application of pelvic girdle questionnairePelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain. | Other | Group 1: Pregnant women diagnosed with GDM (first pregnancy), Group 2:Pregnant women diagnosed with GDM (2nd or 3rd pregnancy), Group 3: Healthy pregnant women (first pregnancy), Group 4:Healthy pregnant women (2nd or 3rd pregnancy) |
Primary outcome
Evaluation of pain
Time frame: Baseline
Measuring of the presence of pain and severity level of pain with body chart and vısual analog scale
Evaluation of test of pelvic girdle
Time frame: Baseline
Measuring of the presence of pain and severity level of pain with pelvic girdle provocation and palpation tests
Evaluation of pelvic girdle questionnaire
Time frame: Baseline
Measuring of the pelvic girdle questionnaire (PGQ) in pregnant women with pelvic girdle pain
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 20 Jan 2022.
- Results publication: PubMed 18259783Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
- 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 24688921Eivazi M, Abadi L. Low back pain in diabetes mellitus and importance of preventive approach. Health Promot Perspect. 2012 Jul 1;2(1):80-8. doi: 10.5681/hpp.2012.010. eCollection 2012.
- 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 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.
- Results publication: PubMed 21596959Stuge B, Garratt A, Krogstad Jenssen H, Grotle M. The pelvic girdle questionnaire: a condition-specific instrument for assessing activity limitations and symptoms in people with pelvic girdle pain. Phys Ther. 2011 Jul;91(7):1096-108. doi: 10.2522/ptj.20100357. Epub 2011 May 19.
- 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 22244365Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012 May;96(2):135-40. doi: 10.1016/j.diabres.2011.12.022. Epub 2012 Jan 12.
- Results publication: PubMed 23506189Martins RF, Pinto e Silva JL. Treatment of pregnancy-related lumbar and pelvic girdle pain by the yoga method: a randomized controlled study. J Altern Complement Med. 2014 Jan;20(1):24-31. doi: 10.1089/acm.2012.0715. Epub 2013 Mar 18.
- Individual participant dataSharing planned: Undecided
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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 Gestational Diabetes and Pelvic Girdle Pain, 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 1 inclusion and 1 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 20 Jan 2022. 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?
Evaluation of pain (time frame: Baseline). The study lists 3 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 NCT04769375, which also lists 9 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 20 Jan 2022.