NCT03835650

Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

Completed Last updated 14 May 2021

What this trial tests

trial in Pelvic Girdle Pain in 105 participants. Completed in 25 February 2021.

Timeline

1 April 2019

Primary endpoint
25 February 2021

25 February 2021

Quick facts

Lead sponsor	Żelazna Medical Centre, LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	105
Start date	1 April 2019
Primary completion	25 February 2021
Estimated completion	25 February 2021
Sites	1 location across Poland

Conditions studied

• Pelvic Girdle Pain — all drugs for Pelvic Girdle Pain →
• Pubic Symphysis Diastasis — all drugs for Pubic Symphysis Diastasis →
• Diastasis Recti — all drugs for Diastasis Recti →

Sponsor

Żelazna Medical Centre, LLC

Who can join

Adults 18 to 45, female only, with Pelvic Girdle Pain or Pubic Symphysis Diastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association Among Pelvic Girdle Pain, Diastasis Recti Abdominis, Pubic Symphysis Width, and Pain Catastrophizing: A Matched Case-Control Study.
   Starzec-Proserpio M, Lipa D, Szymański J, Szymańska A, et al · · 2022 · cited 12× · PMID 35079827 · DOI 10.1093/ptj/pzab311