Postpartum Hemorrhage: Incidence and Risk Factors

NCT05525143 | Completed

• 1 other identifier: PPH
• Study Type: observational
• Target: 2,402
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Incidence of PPH

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

  48 hours

Interventions

Pregnant women who have given birth vaginally or by cesarean section PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Pregnant women who have given birth vaginally or by cesarean section
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (10)

• 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.

  PMID: 25447386 BACKGROUND

• 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.

  PMID: 25103301 BACKGROUND

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

  PMID: 28937571 BACKGROUND

• 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.

  PMID: 31567319 BACKGROUND

• 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.

  PMID: 30211952 BACKGROUND

• 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.

  PMID: 28068990 BACKGROUND

• 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.

  PMID: 29320553 BACKGROUND

• 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.

  PMID: 31437195 BACKGROUND

• 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.

  PMID: 34048966 BACKGROUND

• 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.

  PMID: 17621472 BACKGROUND

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

• Tatiana Besse, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, anesthesiology

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: October 10, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 26, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)