Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03835650
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2019-02-04
Brief Title:
Pelvic Girdle Pain Early Postpartum Underlying Condition and Associated Factors
Sponsor:
Żelazna Medical Centre LLC
Organization:
Żelazna Medical Centre LLC
Study Overview
Official Title:
Pelvic Girdle Pain Early Postpartum Underlying Condition and Associated Factors
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 withor 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 rectiinter-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
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 rectiinter-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None