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Postpartum HemorrhageNCT05525143

Postpartum Hemorrhage: Incidence and Risk Factors

An observational study of Postpartum Hemorrhage, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postpartum hemorrhage(PPH) is a major cause of maternal morbidity and mortality across the world. Incidence of PPH varies in the literature from 2 to 10%, most recent studies find around 10% of PPH and 2% of severe PPH. In this study, the incidence of PPH in the maternal ward of the CHU Brugmann will be analyzed. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Pregnant women who have given birth vaginally or by cesarean section
Type of treatment
Surgery or procedure
How many people
2,402 participants
Where
1 siteBelgium
Study dates
10 Oct 2022to 26 Jul 2023
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 to 60 years
  • Women only
  • Adult

Study population: Pregnant women who have given birth vaginally or by cesarean section at the CHU Brugmann between January 1, 2020 and August 31, 202

Who may be able to join

  • Pregnant women who have given birth vaginally or by cesarean section at the CHU Brugmann between January 1, 2020 and August 31, 2022
  • ≥ 18 years

Who cannot join

  • Age ≤ 18 years
  • Age > 60 years
  • delivery before 25th week of pregnancy
  • delivery outside of the hospital
  • abortion

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU Brugmann

    Brussels, 1020

Other trials in Belgium

About this study

Official title: Incidence and Risk Factors of Postpartum Hemorrhage at the Brugmann University Hospital in Comparison to the Literature

Postpartum hemorrhage(PPH) is a major cause of maternal morbidity and mortality across the world. Incidence of PPH varies in the literature from 2 to 10%, most recent studies find around 10% of PPH and 2% of severe PPH.

In this study, the incidence of PPH in the maternal ward of the CHU Brugmann will be analyzed. This is a tertiary maternal ward with a high proportion of high risk pregnancies with around 3000 admissions per year.

Primary aim of this study is to evaluate the epidemiology of PPH in the CHU Brugmann, incidence and possible underlying causes will be identified and compared to the current literature. A data mining technique will be used to construct a prediction model for PPH.

Being tested
Pregnant women who have given birth vaginally or by cesarean section
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregnant women who have given birth vaginally or by cesarean sectionProcedure or surgery

    Full-term pregnant women who have given birth vaginally or by cesarean section with PPH. Descriptive statistics and possible causal factors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of PPH

    Descriptive statistics of incidence (%) of PPH occuring during the first 48h after delivery.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start10 Oct 2022
  3. Primary completion20 Jul 2023
  4. Study completion26 Jul 2023

Resources

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
2,402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525143
Sponsor's protocol ID
PPH
Status last verified
Jul 2023
First submitted
29 Aug 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deneux-Tharaux C, Bonnet MP, Tort J. [Epidemiology of post-partum haemorrhage]. J Gynecol Obstet Biol Reprod (Paris). 2014 Dec;43(10):936-50. doi: 10.1016/j.jgyn.2014.09.023. Epub 2014 Nov 6. French.

    PubMed 25447386

  • Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

    PubMed 25103301

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

    PubMed 28937571

  • Reale SC, Easter SR, Xu X, Bateman BT, Farber MK. Trends in Postpartum Hemorrhage in the United States From 2010 to 2014. Anesth Analg. 2020 May;130(5):e119-e122. doi: 10.1213/ANE.0000000000004424.

    PubMed 31567319

  • Diaz V, Abalos E, Carroli G. Methods for blood loss estimation after vaginal birth. Cochrane Database Syst Rev. 2018 Sep 13;9(9):CD010980. doi: 10.1002/14651858.CD010980.pub2.

    PubMed 30211952

  • Nyflot LT, Sandven I, Stray-Pedersen B, Pettersen S, Al-Zirqi I, Rosenberg M, Jacobsen AF, Vangen S. Risk factors for severe postpartum hemorrhage: a case-control study. BMC Pregnancy Childbirth. 2017 Jan 10;17(1):17. doi: 10.1186/s12884-016-1217-0.

    PubMed 28068990

  • Girault A, Deneux-Tharaux C, Sentilhes L, Maillard F, Goffinet F. Undiagnosed abnormal postpartum blood loss: Incidence and risk factors. PLoS One. 2018 Jan 10;13(1):e0190845. doi: 10.1371/journal.pone.0190845. eCollection 2018.

    PubMed 29320553

  • Anger H, Durocher J, Dabash R, Winikoff B. How well do postpartum blood loss and common definitions of postpartum hemorrhage correlate with postpartum anemia and fall in hemoglobin? PLoS One. 2019 Aug 22;14(8):e0221216. doi: 10.1371/journal.pone.0221216. eCollection 2019.

    PubMed 31437195

  • Goad L, Rockhill K, Schwarz J, Heyborne K, Fabbri S. Development and validation of a prediction model for postpartum hemorrhage at a single safety net tertiary care center. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100404. doi: 10.1016/j.ajogmf.2021.100404. Epub 2021 May 25.

    PubMed 34048966

  • Ambler G, Omar RZ, Royston P. A comparison of imputation techniques for handling missing predictor values in a risk model with a binary outcome. Stat Methods Med Res. 2007 Jun;16(3):277-98. doi: 10.1177/0962280206074466.

    PubMed 17621472

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Hemorrhage, run by Brugmann University Hospital 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 2 inclusion and 5 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 27 Jul 2023. 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?

Incidence of PPH (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525143, which also lists 10 linked publications.

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 27 Jul 2023.

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