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Clinical Trials/NCT05127642
NCT05127642
Completed
Not Applicable

Hemostatic Assessment of Postpartum Hemorrhage Cases Using Sonoclot Signature

Assiut University1 site in 1 country90 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Postpartum hemorrhage patients
Conditions
Postpartum Hemorrhage
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.
Status
Completed
Last Updated
last month

Overview

Brief Summary

Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.

Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.

There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.

Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.

When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.

Various methods are used to record coagulation profile. One of them is estimation by sonoclot.

Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.

Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
December 25, 2024
Last Updated
last month
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rehab Abdelnasser Mohammed Omran

resident doctor, clinical Pathology department.

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients in childbearing period.
  • Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
  • Patients with causes of Postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc.

Exclusion Criteria

  • Patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage).
  • Patients with miscarriages (bleeding before 22 weeks of gestation) or Antepartum hemorrhage.
  • Traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, Lacerations, hematomas, Uterine inversion, and iatrogenic trauma.

Arms & Interventions

Postpartum hemorrhage patients

Controls (non postpartum hemorrhage patients)

Outcomes

Primary Outcomes

Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.

Time Frame: 3 years

Study Sites (1)

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