Obstetric ComplicationsNCT02823717
Obstetric and Proctology Support of Patients With Perineums Suits
An observational study of Obstetric Complications and Muscle Tear, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Complications, Muscle Tear
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2015to 31 Dec 2023
- How long will I take part?
- 3 Years
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.
Who may be able to join
- All patients over 18 years
- Affiliated to the national system of social security,
- Giving birth during the period of inclusion of the St. Joseph site or Port Royal for whom the diagnosis of severe perineal tear was done.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-Francfe, 75014
About this study
Official title: Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort
Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.
In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.
The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.
Read the detailed description
Main objective / secondary:
Describe exactly the operational management of severe perineal tear (grade III and IV), their context and the factors associated with them occurring, the results of clinical and paraclinical proctology examination carried away from the birth, and study their relationship with the clinical status of patients at 6 months, 1, 2 and 3 years of confinement.
Methodology :
Type prospective, multicentre, non-interventional Study duration: 6 years
- Conditions
- Obstetric Complications, Muscle Tear
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of Bristol Score
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. It is used in both clinical and experimental fields.
Measured: 6 months, 1, 2 and 3 years of birth
Assessment of change of anal incontinence score
The severity of fecal incontinence can be assessed by a scoring system which takes into account the type and frequency of incontinence as well as the extent to which it alters the patient's life. This can also be used to monitor the patient over time, especially after interventions.
Measured: 6 months, 1, 2 and 3 years of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start31 Jan 2015
- Primary completion31 Jan 2018
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationsStudies 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
- 186 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AZRIA Elie, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823717
- Sponsor's protocol ID
- PERINEE COMPLET
- Status last verified
- Apr 2023
- First submitted
- 29 Jun 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort
- ClinicalTrials.gov ID
- NCT02823717
- Acronym / sponsor ID
- PERINEE COMPLET
- Conditions
- Obstetric Complications, Muscle Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- 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.
Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.
In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.
The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.
Detailed description
Main objective / secondary:
Describe exactly the operational management of severe perineal tear (grade III and IV), their context and the factors associated with them occurring, the results of clinical and paraclinical proctology examination carried away from the birth, and study their relationship with the clinical status of patients at 6 months, 1, 2 and 3 years of confinement.
Methodology :
Type prospective, multicentre, non-interventional Study duration: 6 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.
Key inclusion criteria (3 listed)
- All patients over 18 years
- Affiliated to the national system of social security,
- Giving birth during the period of inclusion of the St. Joseph site or Port Royal for whom the diagnosis of severe perineal tear was done.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of change of Bristol Score
Time frame: 6 months, 1, 2 and 3 years of birth
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. It is used in both clinical and experimental fields.
Assessment of change of anal incontinence score
Time frame: 6 months, 1, 2 and 3 years of birth
The severity of fecal incontinence can be assessed by a scoring system which takes into account the type and frequency of incontinence as well as the extent to which it alters the patient's life. This can also be used to monitor the patient over time, especially after interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
AZRIA Elie, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Obstetric Complications and Muscle Tear, run by Fondation Hôpital Saint-Joseph 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 3 inclusion and 1 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 27 Apr 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of Bristol Score (time frame: 6 months, 1, 2 and 3 years of birth). The study lists 2 primary outcomes in all. 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 27 Apr 2023.