Postpartum Hemorrhage: Incidence and Risk Factors

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525143
• Other study ID #: PPH
• Status: Completed
• Start date: October 10, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: July 2023
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2402
• Est. completion date: July 26, 2023
• Est. primary completion date: July 20, 2023
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age = 18 years

• Age > 60 years

• delivery before 25th week of pregnancy

• delivery outside of the hospital

• abortion

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PPH	Descriptive statistics of incidence (%) of PPH occuring during the first 48h after delivery.	48 hours