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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03266432
Acronym
DIC
Enrollment
60
Registered
2017-08-30
Start date
2017-08-28
Completion date
2020-06-30
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DIC Syndrome

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

Interventions

OTHERblood samples

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
prevention of Postoperative development of DICfrom time of operation till 48 hours postopertiveprevention according to the results of thromboelastometry

Secondary

MeasureTime frameDescription
prevention of Complications of massive transfusionfrom time of operation till 48 hours postoperativehypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
Systolic blood pressurefrom time of operation till 48 hours postoperativesystolic blood pressure is measured every hour from time of operation till 48 hours postoperative
diastolic blood pressurefrom time of operation till 48 hours postoperativediastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
heart ratefrom time of operation till 48 hours postoperativeheart rate is recorded every hour from time of operation till 48 hours

Countries

Egypt

Contacts

Primary ContactMohamed kilany, Master
mohamedkelany@aun.edu.eg00201090030029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026