Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT07466719

Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage

Led by Aswan University · Updated on 2026-03-12

50

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare the safety and efficacy of manual syringing versus pneumatic pressure bags for blood transfusion in patients experiencing major obstetric hemorrhage during a cesarean section. It will also evaluate the effectiveness of these methods in rapidly stabilizing patient vital signs. The main questions it aims to answer are:Does manual syringing result in a higher incidence of hemolysis (red blood cell destruction) compared to pneumatic pressure bags?Which method is more effective and faster at achieving hemodynamic stability (restoring normal blood pressure, heart rate, and oxygen levels)?Are there differences between the two methods regarding total blood product usage, transfusion-related complications, and the length of hospital stay?Researchers will compare manual syringing (using 20 mL syringes) to pneumatic pressure bags (inflated to 300 mmHg) to determine which is safer and more efficient for emergency transfusions in resource-constrained environments.Participants will:Be women aged 18-45 years undergoing a cesarean section who are diagnosed with major obstetric hemorrhage (blood loss \>1000 mL or hemodynamic instability).Be randomly assigned to one of two groups to receive their blood transfusion through either the manual syringe method or a pneumatic pressure bag.Receive standard vascular access through multiple peripheral and jugular cannulae.Undergo close monitoring of vital signs to determine the time to stabilization.Provide blood samples at baseline and six hours post-transfusion to measure markers of hemolysis, specifically Lactate Dehydrogenase (LDH) and indirect bilirubin levels.Be monitored for any transfusion-related complications, such as allergic reactions or acute kidney injury, during their hospital stay and for major complications up to 30 days postoperatively

CONDITIONS

Official Title

Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18-45 years undergoing cesarean section
  • Diagnosed major obstetric hemorrhage with blood loss �3e=1000 mL or hemodynamic instability requiring transfusion
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Pre-existing hemolytic conditions such as sickle cell disease or thalassemia
  • Known hypersensitivity to blood products
  • Severe baseline coagulopathy (INR > 2.0 or Platelet count < 50,000/mm�0b3) or established disseminated intravascular coagulation prior to randomization
  • Refusal to receive blood transfusion

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Trial Site Locations

Total: 1 location

1

Aswan University Hospital

Aswān, Egypt

Actively Recruiting

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Research Team

S

Soudy Hammad, lecturer of anesthesia,SICU,

CONTACT

T

Tarek Hemaida, lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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