Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Girdle Pain; Diastasis Recti; Pubic Symphysis Diastasis

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-004
      • Centre of Postgraduate Medical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women in early postpartum period (during hospital stay)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PGP; Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests
no PGP; Patients in early postpartum period, with no symptoms and signs of PGP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastasis Recti: ultrasound measurement of inter-recti distance	measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)	one time assessment, during the hospital stay, within 1st week postpartum
Pubic symphysis distance	assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound	one time assessment, during the hospital stay, within 1st week postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	Assesment of Catastrophizing	one time assessment, during the hospital stay, within 1st week postpartum
Epidural anaesthesia	Time form injection to full cervical dilatation	during labour (Time form injection to full cervical dilatation)
Epidural anaesthaesia2	Time form injection to labour	during labour (Time form injection to labour)
Diastasis Recti: inter-recti distance	measurement of inter-recti distance by palpation examination at the level of umbilicus, 2cm over the umbilicus and 2 cm below	one time assessment, during the hospital stay, within 1st week postpartum

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC
• Collaborators: Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Pain; Pregnancy Complications; Puerperal Disorders; Joint Dislocations; Pelvic Pain; Diastasis, Bone; Pelvic Girdle Pain; Pubic Symphysis Diastasis
• Other Study ID Numbers: PN/19/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No