Impact of Epidural on Trauma of the Genital Tract During Peripartum

November 25, 2025 updated by: Tatiana Besse-Hammer
Peripartum genital tract injuries (PVT) are common after vaginal delivery and can lead to physical, psychological, and functional sequelae. While several risk factors have been established in the literature, the link between epidural analgesia and these injuries remains controversial. The primary objective of this study was to evaluate the impact of epidural analgesia on the occurrence of PVT. Secondary objectives were to examine its association with instrumentation, episiotomy, and induction of labor, to identify independent risk factors for PVT, and to develop a predictive model for the risk of these injuries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8516

Contacts and Locations

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

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women giving birth by vaginal delivery within the CHU Brugmann Hospital, from January 1 2020 till December 31 2002

Description

Inclusion Criteria:

Vaginal delivery within the CHU Brugmann Hospital, from January 1 2020 till December 31 2002

Exclusion Criteria:

  • Incomplete medical files
  • Delivery before 25 weeks of pregnancy
  • Out of Hospital delivery
  • Medical termination of pregnancy (MTP)
  • Cesarean delivery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deliveries with epidural analgesia
Other: Data collection from medical files
Data collection from medical files
Deliveries without epidural analgesia
Other: Data collection from medical files
Data collection from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of peripartum genital tract trauma
Time Frame: At delivery
Peripartum genital tract trauma is defined as any obstetric injury occurring during vaginal delivery, including perineal tears, episiotomies, and uterine ruptures.
At delivery
Type of peripartum genital tract trauma
Time Frame: At delivery
Distribution and severity of trauma (perineal tears from D1 to D4 according to OMS CIM-10 classification, D1 being superficial damage, versus episiotomies versus uterine ruptures).
At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumentation rate
Time Frame: At delivery
Use of forceps, suction cup, spatulas.
At delivery
Labor induction rate
Time Frame: At delivery
Labor induction
At delivery

Collaborators and Investigators

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

Sponsor

Tatiana Besse-Hammer

Investigators

  • Principal Investigator: Seyed Javad Bidgoli, MD, CHU Brugmann

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 (Actual)

December 10, 2024

Primary Completion (Actual)

May 19, 2025

Study Completion (Actual)

May 19, 2025

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CHUB-PeriTRAU

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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