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

NCT06816654 | Completed

• 1 other identifier: CHUB-PERIHPeriPartum
• Study Type: observational
• Target: 5,753
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Epidural anesthesia; Postpartum hemorrhage; Obstetric analgesia; Neuraxial anesthesia; Instrumental delivery; Obstetrical trauma

Outcome Measures

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

  Up to 24 hours after the birth of the baby

Secondary Outcomes (1)

• PPH risk factors

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

Study Arms (1)

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

Data extraction from medical records OTHER

Data extraction from medical records

Vaginal deliveries

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

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatiana Besse-Hammer: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Botti, 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 of Clinical Trial Unit

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 10, 2025
• Study Start: December 12, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)