Pelvic Girdle Pain in Pregnant Women

NCT04769375 | Completed

• 1 other identifier: 31
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes; Pelvic Girdle Pain; Pregnant Woman

Keywords

gestational diabetes mellitus, pregnancy pelvic girdle pain

Outcome Measures

Primary Outcomes (3)

• Evaluation of pain

  Measuring of the presence of pain and severity level of pain with body chart and vısual analog scale

  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

  Baseline

• Evaluation of pelvic girdle questionnaire

  Measuring of the pelvic girdle questionnaire (PGQ) in pregnant women with pelvic girdle pain

  Baseline

Study Arms (4)

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.

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.

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.

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.

Other: Evaluation of pain; Other: Application of pelvic girdle pain tests; Other: Application of pelvic girdle questionnaire

Interventions

Evaluation of pain OTHER

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.

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 tests OTHER

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)

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 questionnaire OTHER

Pelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain.

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)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 18259783 RESULT

• 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.

  PMID: 18763174 RESULT

• 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.

  PMID: 24688921 RESULT

• 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):3342. doi: 10.3390/ijms19113342.

  PMID: 30373146 RESULT

• 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.

  PMID: 31700607 RESULT

• 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.20100357. Epub 2011 May 19.

  PMID: 21596959 RESULT

• 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 health. J Pain. 2015 Mar;16(3):270-82. doi: 10.1016/j.jpain.2014.12.002. Epub 2014 Dec 23.

  PMID: 25540938 RESULT

• 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.

  PMID: 22244365 RESULT

• 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.

  PMID: 23506189 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 20, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-02

Locations

TU (1)