Lesions of the Anal SphincterLOSANCT05001230
Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter
An observational study of Lesions of the Anal Sphincter, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject. The objective of this search is to study of the obstetric lesions of the anal sphincter Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lesions of the Anal Sphincter
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Sep 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 years and older
- Women only
- Adult, Older adult
Study population: Adult woman who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
Who may be able to join
- Adult woman (≥18 years old)
- Patient who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
- Single pregnancy
- 3rd degree or 4th degree perineal tear
- Intact perineum (control group)
- Good understanding of French orally
- Patient accepting to participate in the satisfaction telephone interview and not having expressed her opposition to the reuse of her data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Cesarean delivery
- Multiple pregnancy
- Premature delivery
- stillborn child
- impossibility of providing the subject with enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)
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- Subject under safeguard of justice
- Subject under guardianship or guardianship
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Solène PETRY, MD, 33 3 88 12 63 53, solène.petry@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject.
The objective of this search is to study of the obstetric lesions of the anal sphincter
- Conditions
- Lesions of the Anal Sphincter
- Keywords
- Lesions of the anal sphincter, Anal sphincter, Sexual health
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of obstetric lesions of the anal sphincter
Measured: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesions of the Anal SphincterStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solène PETRY, MD, Principal investigator, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001230
- Sponsor's protocol ID
- 8296
- Acronym
- LOSA
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter
- ClinicalTrials.gov ID
- NCT05001230
- Acronym / sponsor ID
- LOSA / 8296
- Conditions
- Lesions of the Anal Sphincter
- Keywords
- Lesions of the anal sphincter, Anal sphincter, Sexual health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 11 Aug 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.
Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject.
The objective of this search is to study of the obstetric lesions of the anal sphincter
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult woman who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
Key inclusion criteria (7 listed)
- Adult woman (≥18 years old)
- Patient who gave birth at term to a child born living in the maternity hospitals of Strasbourg University Hospital between 01/01/2019 and 12/31/2019
- Single pregnancy
- 3rd degree or 4th degree perineal tear
- Intact perineum (control group)
Key exclusion criteria (9 listed)
- Subject having expressed opposition to participating in the study
- Cesarean delivery
- Multiple pregnancy
- Premature delivery
- stillborn child
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
Retrospective study of obstetric lesions of the anal sphincter
Time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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.
Solène PETRY, MD principal investigator
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
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 Lesions of the Anal Sphincter, run by University Hospital, Strasbourg, France 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 7 inclusion and 9 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 26 Jan 2022. 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 Solène PETRY, MD (33 3 88 12 63 53, solène.petry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of obstetric lesions of the anal sphincter (time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]). 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 26 Jan 2022.