Pelvic Girdle Pain in Pregnant Women

Gestational Diabetes Clinical Trial

Official title:

Investigation of the Effect of Gestational Diabetes Mellitus on the Pelvic Girdle Pain and Symptom Severity in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769375
• Other study ID #: 31
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: February 2021
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 20, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pelvic Girdle Pain
• Pregnant Woman

Intervention

Other:
• Evaluation of pain
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 tests
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 questionnaire
Pelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain.

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View Citation

Eivazi 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. — View Citation

Martins 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. — View Citation

Molsted 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. — View Citation

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 he — View Citation

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). pii: E3342. doi: 10.3390/ijms19113342. Review. — View Citation

Stuge 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.2010 — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain	Measuring of the presence of pain and severity level of pain with body chart and visual analog scale	Baseline
Primary	Evaluation of test of pelvic girdle	Measuring of the presence of pain and severity level of pain with pelvic girdle provocation and palpation tests	Baseline
Primary	Evaluation of pelvic girdle questionnaire	Measuring of the pelvic girdle questionnaire (PGQ) in pregnant women with pelvic girdle pain	Baseline