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OpenTrials
Completed

NCT Number: NCT07255014

Impact of Epidural on Trauma of the Genital Tract During Peripartum

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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Key information

Conditions

Peripartum Genital Tract Trauma

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection from medical files

Other

Data collection from medical files

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Instrumentation rate

    Time frame: At delivery

    Use of forceps, suction cup, spatulas.

  2. Labor induction rate

    Time frame: At delivery

    Labor induction

Sponsors and collaborators

Lead sponsor

Tatiana Besse-Hammer

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.