Recovery of FunctionPPFRNCT04882722
Postpartum Pelvic Floor Rehabilitation and Information Provided by the Health Care Providers
An observational study of Recovery of Function, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recovery of Function
- What is being tested?
- Questionnaire
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women undergoing pelvic floor rehabilitation at the Departmental Hospital Center of Vendee
Who may be able to join
- All women undergoing postpartum pelvic floor rehabilitation at the Departmental Hospital Center of Vendee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Departmental Hospital Center of Vendee
La Roche-sur-Yon, 85000
Guillaume DUCARME, guillaume.ducarme@chd-vendee.fr
Guillaume Ducarme, Dr
About this study
Official title: Opinion Survey on Postpartum Pelvic Floor Rehabilitation According to the Quality of Information Provided by the Health Care Providers
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.
Read the 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
- Conditions
- Recovery of Function
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self-questionnaire reported before the first PPFR session and after the last session
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start25 May 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery of FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, Dr, Principal investigator, Departmental Hospital Center of Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882722
- Sponsor's protocol ID
- CHD21_0027
- Acronym
- PPFR
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opinion Survey on Postpartum Pelvic Floor Rehabilitation According to the Quality of Information Provided by the Health Care Providers
- ClinicalTrials.gov ID
- NCT04882722
- Acronym / sponsor ID
- PPFR / CHD21_0027
- Conditions
- Recovery of Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women undergoing pelvic floor rehabilitation at the Departmental Hospital Center of Vendee
Key inclusion criteria (1 listed)
- All women undergoing postpartum pelvic floor rehabilitation at the Departmental Hospital Center of Vendee
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSelf-questionnaire reported before the first PPFR session and after the last session | Other | – |
Primary outcome
Overall experience of the PPFR according to information given by the health care providers
Time frame: through study completion, an average of 5 weeks
Self-evaluation of the overall experience of postpartum pelvic floor rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume DUCARME, Dr principal investigator
Departmental Hospital Center of Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recovery of Function, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnès Dorion (251446380 ext. +33, agnes.dorion@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall experience of the PPFR according to information given by the health care providers (time frame: through study completion, an average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.