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CompletedNCT07255014Updated Nov 28, 2025

Impact of Epidural on Trauma of the Genital Tract During Peripartum

An observational study in Peripartum Genital Tract Trauma, sponsored by Tatiana Besse-Hammer. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Tatiana Besse-Hammer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,516
Ages
18 Years and older
Sex
Female
01

Study summary

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.

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Conditions studied

  • Peripartum Genital Tract Trauma
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In context

Lead sponsor

Tatiana Besse-Hammer is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,516 participants (actual)
Patient registry
No

Groups and cohorts

  • Deliveries with epidural analgesia

    Other: Data collection from medical files

  • Deliveries without epidural analgesia

    Other: Data collection from medical files

Interventions

  • OtherData collection from medical files

    Data collection from medical files

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What researchers measure

Primary outcomes

  1. Rate of peripartum genital tract trauma

    Peripartum genital tract trauma is defined as any obstetric injury occurring during vaginal delivery, including perineal tears, episiotomies, and uterine ruptures.

    Time frame: At delivery

  2. Type of peripartum genital tract trauma

    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).

    Time frame: At delivery

Secondary outcomes

  1. Instrumentation rate

    Use of forceps, suction cup, spatulas.

    Time frame: At delivery

  2. Labor induction rate

    Labor induction

    Time frame: At delivery

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Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in May 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2025
First posted
Nov 28, 2025
StartActual
Dec 10, 2024
Primary completionActual
May 19, 2025
CompletionActual
May 19, 2025
Last update
Nov 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07255014
Lead sponsor
Tatiana Besse-Hammer
Responsible party
Tatiana Besse-Hammer (Head Physician of Clinical Trial Unit, Brugmann University Hospital) — Sponsor-investigator
First posted
Nov 28, 2025
Start date
Dec 10, 2024
Primary completion
May 19, 2025
Completion
May 19, 2025
Last update
Nov 28, 2025

Study contacts

Seyed Javad BIDGOLI, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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