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CompletedNCT06816654Updated Feb 10, 2025

Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage

An observational study in Postpartum Hemorrhage, 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 2025-02-10.

Sponsored by Tatiana Besse-Hammer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,753
Ages
18 Years and older
Sex
Female
01

Study summary

Postpartum hemorrhage (PPH) is a major complication of childbirth. Epidurals are often implicated in the onset of postpartum hemorrhages. Given the paradoxical data in the literature, the investigators wished to retrospectively evaluate the impact of epidurals on the risk of PPH, instrumental delivery and the occurrence of PPH risk factors.

The investigators retrospectively analyzed 5753 records of patients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021. The primary objective was to assess whether epidurals pose a risk of postpartum hemorrhage. Secondly, the investigators assessed whether epidurals pose a greater risk of instrumentation of delivery and emergence of PPH risk factors.

02

Conditions studied

  • Postpartum Hemorrhage

Keywords

  • Epidural anesthesia
  • Postpartum hemorrhage
  • Obstetric analgesia
  • Neuraxial anesthesia
  • Instrumental delivery
  • Obstetrical trauma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021

Inclusion criteria

  • Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021.

Exclusion criteria

Exclusion Criteria:

  • Patients who gave birth before 25 weeks.
  • Patients who gave birth outside of hospital.
  • Patients who had recourse to a medical termination of pregnancy (MTP).
  • Patients who gave birth by cesarean section.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,753 participants (actual)
Patient registry
No

Groups and cohorts

  • Vaginal deliveries

    Patients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021.

    Other: Data extraction from medical records

Interventions

  • OtherData extraction from medical records

    Data extraction from medical records

05

What researchers measure

Primary outcomes

  1. Postpartum blood loss

    Total blood loss is analyzed according to a standardized protocol: use of the calibrated field of the collection bag and of a precision scale to weigh the blood soaked compresses

    Time frame: Up to 24 hours after the birth of the baby

Secondary outcomes

  1. PPH risk factors

    Presence/absence of one or more PPH risk factors (yes/no) such as : uterine atony, placental abnormalities, obstetric trauma, and coagulopathy.

    Time frame: Data extraction in medical files from January 1st 2020 till December 31th 2021

06

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06816654
Lead sponsor
Tatiana Besse-Hammer
Responsible party
Tatiana Besse-Hammer (Head of Clinical Trial Unit, Brugmann University Hospital) — Sponsor-investigator
First posted
Feb 10, 2025
Start date
Dec 12, 2023
Primary completion
May 22, 2024
Completion
May 22, 2024
Last update
Feb 10, 2025

Study contacts

Thomas Botti, 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 ↗

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

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