Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa

NCT ID: NCT03266432

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2020-06-30

Brief Summary

Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.

Detailed Description

Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects

Conditions

DIC Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

60 pregnant women

60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention

Group Type: OTHER

blood samples

Intervention Type: OTHER

three blood samples : first one pre intervention and the other two blood samples post-intervention

Interventions

blood samples

three blood samples : first one pre intervention and the other two blood samples post-intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA physical status I or II
• Age: ≥ 18 years
• Patients with all types of placenta previa
• Eligible for general anesthesia
• Elective cesarean section
• Singleton term pregnancy
• Normal coagulation profile: prothrombin time (PT), activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level

Exclusion Criteria

• Parturient refusal
• Known coagulopathy
• Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.
• Eclampsia and preeclampsia
• Emergency surgeries
• Foetal abnormalities
• Drug induced thrombocytopenia as antibiotics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Kilany

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ragaa Ahmed Herdan, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut university hopitals

Locations

Assiut university hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed kilany, Master

Role: CONTACT

mohamedkelany@aun.edu.eg

00201090030029

Facility Contacts

Alaa Mohamed Ahmed Attia, MD

Role: primary

alaa.atya@med.au.edu.eg

01099923117

Other Identifiers

thromboelastometryDIC

Identifier Type: -

Identifier Source: org_study_id