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Impact of Epidural on Trauma of the Genital Tract During Peripartum

NCT ID: NCT07255014

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Peripartum Genital Tract Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Deliveries with epidural analgesia

Data collection from medical files

Intervention Type OTHER

Data collection from medical files

Deliveries without epidural analgesia

Data collection from medical files

Intervention Type OTHER

Data collection from medical files

Interventions

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Data collection from medical files

Data collection from medical files

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tatiana Besse-Hammer

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Besse-Hammer

Head Physician of Clinical Trial Unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seyed Javad BIDGOLI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB-PeriTRAU

Identifier Type: -

Identifier Source: org_study_id