Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

Pelvic Girdle Pain Clinical Trial

Official title:

Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835650
• Other study ID #: PN/19/2019
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: February 25, 2021

Study information

• Verified date: May 2021
• Source: Zelazna Medical Centre, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti
• Pelvic Girdle Pain
• Pubic Symphysis Diastasis

Locations

Country	Name	City	State
Poland	Centre of Postgraduate Medical Education	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC	Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain Catastrophizing Scale	Assesment of Catastrophizing	one time assessment, during the hospital stay, within 1st week postpartum
Secondary	Epidural anaesthesia	Time form injection to full cervical dilatation	during labour (Time form injection to full cervical dilatation)
Secondary	Epidural anaesthaesia2	Time form injection to labour	during labour (Time form injection to labour)
Secondary	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