Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01820013
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2013-03-15
Brief Title:
Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments
Sponsor:
University of Plymouth
Organization:
University of Plymouth
Study Overview
Official Title:
Management of Antenatal Pelvic Girdle Pain Study MAPS a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments
Status:
COMPLETED
Status Verified Date:
2015-12
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:
MAPS
Brief Summary:
This blinded randomized comparative trial aims to determine the effectiveness of a customized Dynamic Elastomeric Fabric Orthoses DEFO compared to a standard pelvic belt in a reducing pregnancy-related pelvic girdle pain PGP b optimizing activity levels in pregnant women with PGP c improving quality of life for pregnant women with PGP d cost effectiveness
Detailed Description:
Pelvic girdle pain PGP occurs in an estimated 70 of pregnant women of whom 25 have severe pain and 8 significant disability Current methods of management such as the use of rigid pelvic belts are limited in their effectiveness The Dynamic Elastomeric Fabric Orthoses DEFO has recently proven beneficial in managing PGP in athletes There is a need to explore the potential use of DEFO for managing PGP during pregnancy The primary aim of the study is to compare the effectiveness of a DEFO to a rigid off the shelf pelvic support belt in terms of its effectiveness in reducing PGP during pregnancy The secondary aims of the study are to compare the effectiveness of the DEFO to the rigid off the shelf pelvic support belt in a optimizing activity levels in pregnant women with PGP bimproving quality of life for pregnant women with PGP The relative cost effectiveness of these two interventions will also be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None