Symptoms and Function During and After Pregnancy | NCT01787266

Studies
Symptoms and Function During and After Pregnancy

NCT01787266

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Pelvic Girdle Pain

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
129/12-303.0	Other Grant/Funding Number	The Norwegian FONDET

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 31, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to:

describe degree of symptoms and disability during and after pregnancy
to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing
to examine the responsiveness of The Pelvic Girdle Questionnaire

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Label	Type	Description	Intervention Names
1		pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the pelvic girdle questionnaire		10 weeks postpartum

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity, Numeric rating scale		10 weeks postpartum

Other Outcomes

Measure	Description	Time Frame
Short Form -8 (SF-8)		10 weeks postpartum

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnancy week 32-36
Understand and read/write a questionnaire in Norwegian or English

Exclusion Criteria:

Not able to understand and fill in a questionnaire

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

pregnant women in week 32 - 36

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D059388	Pelvic Girdle Pain

Ancestor Terms

ID	Term
D059352	Musculoskeletal Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided