Impact of Epidural on Trauma of the Genital Tract During Peripartum

NCT07255014 | Completed

• 1 other identifier: CHUB-PeriTRAU
• Study Type: observational
• Target: 8,516
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripartum Genital Tract Trauma

Outcome Measures

Primary Outcomes (2)

• 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.

  At delivery

• 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).

  At delivery

Secondary Outcomes (2)

• Instrumentation rate

  At delivery

• Labor induction rate

  At delivery

Study Arms (2)

Deliveries with epidural analgesia

Other: Data collection from medical files

Deliveries without epidural analgesia

Other: Data collection from medical files

Interventions

Data collection from medical files OTHER

Data collection from medical files

Deliveries with epidural analgesia; Deliveries without epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tatiana Besse-Hammer: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Officials

• Seyed Javad BIDGOLI, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Physician of Clinical Trial Unit

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: November 28, 2025
• Study Start: December 10, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

BE (1)