search
Back to results

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

Primary Purpose

DIC Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for DIC Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Assiut university hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

60 pregnant women

Arm Description

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

Outcomes

Primary Outcome Measures

prevention of Postoperative development of DIC
prevention according to the results of thromboelastometry

Secondary Outcome Measures

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
Systolic blood pressure
systolic blood pressure is measured every hour 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
heart rate
heart rate is recorded every hour from time of operation till 48 hours

Full Information

First Posted
August 28, 2017
Last Updated
July 9, 2019
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03266432
Brief Title
Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa
Acronym
DIC
Official Title
Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DIC Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
60 pregnant women
Arm Type
Other
Arm Description
60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
three blood samples : first one pre intervention and the other two blood samples post-intervention
Primary Outcome Measure Information:
Title
prevention of Postoperative development of DIC
Description
prevention according to the results of thromboelastometry
Time Frame
from time of operation till 48 hours postopertive
Secondary Outcome Measure Information:
Title
prevention of Complications of massive transfusion
Description
hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
Time Frame
from time of operation till 48 hours postoperative
Title
Systolic blood pressure
Description
systolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Time Frame
from time of operation till 48 hours postoperative
Title
diastolic blood pressure
Description
diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Time Frame
from time of operation till 48 hours postoperative
Title
heart rate
Description
heart rate is recorded every hour from time of operation till 48 hours
Time Frame
from time of operation till 48 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed kilany, Master
Phone
00201090030029
Email
mohamedkelany@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ragaa Ahmed Herdan, MD
Organizational Affiliation
Assiut university hopitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Mohamed Ahmed Attia, MD
Phone
01099923117
Email
alaa.atya@med.au.edu.eg
First Name & Middle Initial & Last Name & Degree
Nawal Abdel-aziz Jadel-Rab Abdullah, MD
First Name & Middle Initial & Last Name & Degree
Alaa Mohamed Ahmed Attia, MD
First Name & Middle Initial & Last Name & Degree
ragaa Ahmed Herdan, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs