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

February 6, 2025 updated by: Tatiana Besse-Hammer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5753

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Data extraction from medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum blood loss
Time Frame: Up to 24 hours after the birth of the baby
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
Up to 24 hours after the birth of the baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPH risk factors
Time Frame: Data extraction in medical files from January 1st 2020 till December 31th 2021
Presence/absence of one or more PPH risk factors (yes/no) such as : uterine atony, placental abnormalities, obstetric trauma, and coagulopathy.
Data extraction in medical files from January 1st 2020 till December 31th 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatiana Besse-Hammer

Investigators

  • Principal Investigator: Thomas Botti, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Actual)

May 22, 2024

Study Completion (Actual)

May 22, 2024

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-PERIHPeriPartum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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