Postpartum Pelvic Floor Rehabilitation and Information Pr... | NCT04882722

Studies
Postpartum Pelvic Floor Rehabilitation and Information Provided by the Health Care Providers

NCT04882722

Sponsor

Centre Hospitalier Departemental Vendee

Status

Unknown status

Last Update Posted

Jul 30, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Recovery of Function

Interventions

Questionnaire

Countries

France

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

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Apr 28, 2021

First Submission Date that Met QC Criteria

May 6, 2021

First Posted Date

May 12, 2021Actual

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

Jul 29, 2021

Last Update Posted Date

Jul 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 aim of this work is to evaluate the experience of Postpartum Pelvic Floor Rehabilitation (PPFR) according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the patient.

Detailed Description

Postpartum Pelvic Floor Rehabilitation is an important central stage of the postpartum period. It allows, if it is well done, to reduce complications related to childbirth, (pelvic floor disorders: urinary, sexual or anal disorders ) and to increase quality of life of women in postpartum period.

But, what about the woman's opinion and experience of PPFR? Previous studies have evaluated the effectiveness of PPFR but not the woman's experience.

It is interesting to evaluate the experience of PPFR according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the women

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Self-questionnaire reported before the first PPFR session and after the last session

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall experience of the PPFR according to information given by the health care providers	Self-evaluation of the overall experience of postpartum pelvic floor rehabilitation	through study completion, an average of 5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women undergoing postpartum pelvic floor rehabilitation at the Departmental Hospital Center of Vendee

Exclusion Criteria:

Refusal to participate in the study
Patient did not complete all her PPFR sessions at the Departmental Hospital Center of Vendee
Patient unable to understand the protocol, read the information note and answer the questionnaires
Patient under tutelage, curatorship, mandate of future protection, family habilitation

Accepts Healthy Volunteers

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

All women undergoing pelvic floor rehabilitation at the Departmental Hospital Center of Vendee

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agnès Dorion	Contact	251446380	+33	agnes.dorion@chd-vendee.fr

Overall Officials

Name	Affiliation	Role
Guillaume DUCARME, Dr	Departmental Hospital Center of Vendee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departmental Hospital Center of Vendee	Recruiting	La Roche-sur-Yon		85000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided