Hemostatic Assessment of Postpartum Hemorrhage Using Sonoclot Signature

Not yet recruiting

• Conditions: Postpartum Hemorrhage

• Registration Number: NCT05127642
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23
• Study Start: 2024-12-01
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. patients in childbearing period.
2. Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
3. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.	3 years