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

DIC Syndrome Clinical Trial

— DIC  

Official title:

Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03266432
• Other study ID #: thromboelastometryDIC
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Mohamed kilany, Master
• Phone: 00201090030029
• Email: mohamedkelany[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• DIC Syndrome
• Disseminated Intravascular Coagulation
• Placenta Previa

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of Postoperative development of DIC	prevention according to the results of thromboelastometry	from time of operation till 48 hours postopertive
Secondary	prevention of Complications of massive transfusion	hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality	from time of operation till 48 hours postoperative
Secondary	Systolic blood pressure	systolic blood pressure is measured every hour from time of operation till 48 hours postoperative	from time of operation till 48 hours postoperative
Secondary	diastolic blood pressure	diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative	from time of operation till 48 hours postoperative
Secondary	heart rate	heart rate is recorded every hour from time of operation till 48 hours	from time of operation till 48 hours postoperative