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

Completed

• Conditions: Postpartum Hemorrhage

• Registration Number: NCT06816654
• Lead Sponsor: Tatiana Besse-Hammer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5753

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postpartum blood loss	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

Secondary Outcome Measures

Name	Time	Method
PPH risk factors	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.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium