Postpartum HemorrhageNCT06816654
Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage, run by Tatiana Besse-Hammer at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Data extraction from medical records
- How many people
- 5,753 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2023to 22 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021
Who may be able to join
- Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Data extraction from medical records
- Keywords
- Epidural anesthesia, Postpartum hemorrhage, Obstetric analgesia, Neuraxial anesthesia, Instrumental delivery, Obstetrical trauma
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical recordsOther
Data extraction from medical records
| Study group | Role | What they receive |
|---|---|---|
| Vaginal deliveries | Patients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021. Receives: Other: Data extraction from medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Data extraction in medical files from January 1st 2020 till December 31th 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start12 Dec 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatiana Besse-Hammer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Thomas Botti, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816654
- Sponsor's protocol ID
- CHUB-PERIHPeriPartum
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06816654
- Acronym / sponsor ID
- CHUB-PERIHPeriPartum
- Conditions
- Postpartum Hemorrhage
- Keywords
- Epidural anesthesia, Postpartum hemorrhage, Obstetric analgesia, Neuraxial anesthesia, Instrumental delivery, Obstetrical trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,753 participants (actual)
- Lead sponsor
- Tatiana Besse-HammerUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal deliveries | – | Other: Data extraction from medical recordsPatients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021
Key inclusion criteria (1 listed)
- Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical recordsData extraction from medical records | Other | Vaginal deliveries |
Primary outcome
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
1 secondary outcome
PPH risk factors
Time frame: Data extraction in medical files from January 1st 2020 till December 31th 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Botti, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Tatiana Besse-Hammer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum blood loss (time frame: Up to 24 hours after the birth of the baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.