Pelvic Girdle Pain in Pregnant Women

NCT ID: NCT04769375

Last Updated: 2022-01-20

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-08-20

Brief Summary

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

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.

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.

Gestational Diabetes Pelvic Girdle Pain Pregnant Woman

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 diagnosed with GDM (first pregnancy)

This group will consist of women with gestational diabetes mellitus according to routine control tests in their first pregnancy.

Evaluation of pain

Intervention Type 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.

Application of pelvic girdle pain tests

Intervention Type 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)

Application of pelvic girdle questionnaire

Intervention Type OTHER

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

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.

Evaluation of pain

Intervention Type 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.

Application of pelvic girdle pain tests

Intervention Type 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)

Application of pelvic girdle questionnaire

Intervention Type OTHER

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

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.

Evaluation of pain

Intervention Type 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.

Application of pelvic girdle pain tests

Intervention Type 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)

Application of pelvic girdle questionnaire

Intervention Type OTHER

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

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.

Evaluation of pain

Intervention Type 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.

Application of pelvic girdle pain tests

Intervention Type 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)

Application of pelvic girdle questionnaire

Intervention Type OTHER

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

Interventions

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

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.

Intervention Type OTHER

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)

Intervention Type OTHER

Application of pelvic girdle questionnaire

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

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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Saglık Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18259783 (View on PubMed)

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.

Reference Type RESULT
PMID: 18763174 (View on PubMed)

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.

Reference Type RESULT
PMID: 24688921 (View on PubMed)

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.

Reference Type RESULT
PMID: 30373146 (View on PubMed)

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.

Reference Type RESULT
PMID: 31700607 (View on PubMed)

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.

Reference Type RESULT
PMID: 21596959 (View on PubMed)

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.

Reference Type RESULT
PMID: 25540938 (View on PubMed)

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.

Reference Type RESULT
PMID: 22244365 (View on PubMed)

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.

Reference Type RESULT
PMID: 23506189 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Late Postpartum Period and Pain
NCT06745752 COMPLETED
FETAL MOVEMENT COUNTING
NCT05361265 COMPLETED NA
Effect of Yoga Training on Nausea and Pain
NCT07000487 NOT_YET_RECRUITING NA