NCT04882722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 30, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 28, 2021

Last Update Submit

July 29, 2021

Conditions

Recovery of Function

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

QuestionnaireOTHER

Self-questionnaire reported before the first PPFR session and after the last session

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmental Hospital Center of Vendee

La Roche-sur-Yon, 85000, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guillaume DUCARME, Dr

    Departmental Hospital Center of Vendee

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnès Dorion

CONTACT

251446380agnes.dorion@chd-vendee.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 12, 2021

Study Start

May 25, 2021

Primary Completion

December 31, 2021

Study Completion

February 1, 2022

Last Updated

July 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)