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

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

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.

Study Overview

• Status: Unknown
• Conditions: DIC Syndrome
• Intervention / Treatment: Other: blood samples

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed kilany, Master; Phone Number: 00201090030029; Email: mohamedkelany@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut university hospitals
    • Contact: Alaa Mohamed Ahmed Attia, MD; Phone Number: 01099923117; Email: alaa.atya@med.au.edu.eg
    • Principal Investigator: Nawal Abdel-aziz Jadel-Rab Abdullah, MD
    • Principal Investigator: Alaa Mohamed Ahmed Attia, MD
    • Principal Investigator: ragaa Ahmed Herdan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 60 pregnant women; 60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention	Other: blood samples; three blood samples : first one pre intervention and the other two blood samples post-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevention of Postoperative development of DIC	prevention according to the results of thromboelastometry	from time of operation till 48 hours postopertive

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
heart rate	heart rate is recorded every hour from time of operation till 48 hours	from time of operation till 48 hours postoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: ragaa Ahmed Herdan, MD, Assiut university hopitals

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: thromboelastometryDIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No