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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 10, 2019
July 1, 2019
2.8 years
August 28, 2017
July 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
prevention of Postoperative development of DIC
prevention according to the results of thromboelastometry
from time of operation till 48 hours postopertive
Secondary Outcomes (4)
prevention of Complications of massive transfusion
from time of operation till 48 hours postoperative
Systolic blood pressure
from time of operation till 48 hours postoperative
diastolic blood pressure
from time of operation till 48 hours postoperative
heart rate
from time of operation till 48 hours postoperative
Study Arms (1)
60 pregnant women
OTHER60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention
Interventions
three blood samples : first one pre intervention and the other two blood samples post-intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospitals
Asyut, 71515, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ragaa Ahmed Herdan, MD
Assiut university hopitals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
August 28, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
July 10, 2019
Record last verified: 2019-07