Clinical trial NCT03266432: Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa
Official title: Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DIC Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: prevention of Postoperative development of DIC
timeFrame: from time of operation till 48 hours postopertive
Secondary outcomes:
measure: prevention of Complications of massive transfusion
timeFrame: from time of operation till 48 hours postoperative
measure: Systolic blood pressure
timeFrame: from time of operation till 48 hours postoperative
measure: diastolic blood pressure
timeFrame: from time of operation till 48 hours postoperative
measure: heart rate
timeFrame: from time of operation till 48 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut university hopitals
name: ragaa Ahmed Herdan, MD
role: PRINCIPAL_INVESTIGATOR
References: