Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter (LOSA)

January 25, 2022 updated by: University Hospital, Strasbourg, France

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Solène PETRY, MD
        • Sub-Investigator:
          • Odile WEBER, Midwife student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.)
  • Subject under safeguard of justice
  • Subject under guardianship or guardianship
  • Subject under guardianship, curatorship or safeguard of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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]
Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Solène PETRY, MD, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (ACTUAL)

August 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8296 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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