Pelvic Girdle Pain in Pregnant Women

January 19, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • İstanbul Sağlık Bilimleri University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pain
Time Frame: Baseline
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
Time Frame: Baseline
Measuring of the presence of pain and severity level of pain with pelvic girdle provocation and palpation tests
Baseline
Evaluation of pelvic girdle questionnaire
Time Frame: Baseline
Measuring of the pelvic girdle questionnaire (PGQ) in pregnant women with pelvic girdle pain
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 20, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31 (Other Identifier: IASO Thessalias)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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