Hemostatic Assessment of Postpartum Hemorrhage Using Sonoclot Signature

Assiut University

Status: Not yet enrolling

Conditions: Postpartum Hemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT05127642

HAOPPHCUSS

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

Postpartum hemorrhage patients

Controls (non postpartum hemorrhage patients)