Pelvic Girdle Pain in Pregnant Women

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT04769375
Collaborator
(none)
200
1
4.6
43.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of pain
  • Other: Application of pelvic girdle pain tests
  • Other: Application of pelvic girdle questionnaire

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of the Effect of Gestational Diabetes Mellitus on the Pelvic Girdle Pain and Symptom Severity in Pregnant Women
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 20, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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.

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)

Other: Application of pelvic girdle questionnaire
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.

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.

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)

Other: Application of pelvic girdle questionnaire
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.

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.

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)

Other: Application of pelvic girdle questionnaire
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.

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.

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)

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of pain [Baseline]

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

  2. Evaluation of test of pelvic girdle [Baseline]

    Measuring of the presence of pain and severity level of pain with pelvic girdle provocation and palpation tests

  3. Evaluation of pelvic girdle questionnaire [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Saglık Bilimleri University İstanbul Turkey

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT04769375
Other Study ID Numbers:
  • 31
First Posted:
Feb 24, 2021
Last Update Posted:
Jan 20, 2022
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022