Screening for Pregnancy Related Pelvic Girdle Pain

NCT05382845 | Recruiting

• 1 other identifier: BlekingCCH
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

To perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop PPGP with those who don't.

Conditions

Pelvic Girdle Pain

Outcome Measures

Primary Outcomes (1)

• Correlation between pain provocation tests, different risk factors and full time sick-leave.

  Screening of symptom free pregnant women at their first visit in Maternity care using pain provocation tests of the pelvic joints, together with known risk factors for Pregnancy related Pelvic Girdle Pain (PPGP), and a plausible association with the primary outcome full time sick-leave due to PPGP.

  Approximately six months for each participant

Study Arms (1)

Pregnant women without symptoms of pregnancy related pelvic girdle pain

OTHER

There is only one arm in this study. The intervention consists of tests to rule out ongoing pelvic pain, manual pain provocation tests, and questionnaire.

Diagnostic Test: Manual pain provocation tests

Interventions

Manual pain provocation tests DIAGNOSTIC_TEST

Validated and empirical pain provocation tests of the pelvic joints will be performed, both to exclude ongoing symptoms, and to diagnose one or several dysfunctions. The participants will be asked questions regarding previous symptoms, traumas, type of profession etc.

Also known as: Questionnaire

Pregnant women without symptoms of pregnancy related pelvic girdle pain

Eligibility Criteria

• Gender Eligibility Details: It is still not possible for other than women to become pregnant.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.

You may not qualify if:

• Fibromyalgia
• sick-leave
• working at home
• treatment of the pelvic joints during the pregnancy

Sponsors & Collaborators

• Blekinge County Council Hospital: lead
• Lund University: collaborator

Study Sites (1)

The Region Hospital of Blekinge County

Karlskrona, Blekinge County, SE-371 81, Sweden

RECRUITING

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stina Lilje, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stina Lilje, PhD

CONTACT

+46708233332; stina.lilje@ki.se; titti.lilje@gmail.com

Maria Ekelin, PhD

CONTACT

+46703303069; maria.ekelin@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prediction modelling, where risk factors such as earlier trauma to the pelvis, earlier low back pain, earlier pregnancy related pelvic girdle pain, physically demanding job, contraception and the outcomes of the pain provocation tests will predict to what degree a woman is at risk of developing symptoms.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: May 19, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 6 months after publication
• Access Criteria: Upon reasonable request

Locations

SE (1)