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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
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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

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Keywords

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

Postpartum Hemorrhage

469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.

This study's enrollment of 5,753 is above the median of 169 across 96 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

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

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

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

  • 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.
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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

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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

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Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in May 2024, 5 months.

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

Registered
Jan 31, 2025
First posted
Feb 10, 2025
StartActual
Dec 12, 2023
Primary completionActual
May 22, 2024
CompletionActual
May 22, 2024
Last update
Feb 10, 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 Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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