Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

NCT ID: NCT03835650

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-02-25

Brief Summary

Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery.

Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess the differences between females with severe postpartum PGP, mild and moderate PGP and with no PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing).

Materials and methods: Because of low incidence of researched conditions, a case control study will be the study design of choice. The subjects with PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated.

Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. The study will bring information about the possible underlying cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.

Conditions

Pelvic Girdle Pain; Pubic Symphysis Diastasis; Diastasis Recti

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PGP

Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests

No interventions assigned to this group

no PGP

Patients in early postpartum period, with no symptoms and signs of PGP

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Natural labour or vacuum extractor or forceps
• for the study group - pain due to PGP confirmed with dedicated functional tests
• for control group with no pain - no pain due to PGP
• agreement to participate

Exclusion Criteria

• diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia
• major peri-partum events like internal haemorrhage, pelvic fracture

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: collaborator

Żelazna Medical Centre, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre of Postgraduate Medical Education

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

PN/19/2019

Identifier Type: -

Identifier Source: org_study_id