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

Not Applicable

• Conditions: DIC Syndrome
• Interventions: Other: blood samples

• Registration Number: NCT03266432
• Lead Sponsor: Assiut University

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

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
prevention of Postoperative development of DIC	from time of operation till 48 hours postopertive	prevention according to the results of thromboelastometry

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	from time of operation till 48 hours postoperative	systolic blood pressure is measured every hour from time of operation till 48 hours postoperative
prevention of Complications of massive transfusion	from time of operation till 48 hours postoperative	hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
diastolic blood pressure	from time of operation till 48 hours postoperative	diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
heart rate	from time of operation till 48 hours postoperative	heart rate is recorded every hour from time of operation till 48 hours

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt