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

March 10, 2026 updated by: Soudy Salah Hammad, Aswan University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-center, randomized controlled clinical trial (Phase III) is designed to evaluate and compare two common methods for rapid blood transfusion-manual syringing and pneumatic pressure bags-in the specific context of major obstetric hemorrhage (MOH) during cesarean sections. The study is conducted at Aswan University Hospital in Egypt, where both techniques are currently employed in emergency settings, yet a systematic evaluation of their relative safety and clinical efficacy is lacking.Background and RationaleMajor obstetric hemorrhage remains a leading cause of maternal mortality worldwide, particularly in developing countries where it accounts for approximately 27% of maternal deaths. During a cesarean section, a blood loss exceeding 1000 mL is defined by the World Health Organization as postpartum hemorrhage, requiring immediate intervention to restore circulating volume and prevent life-threatening complications.In resource-limited environments, clinicians often rely on:Manual Syringing: Using 20 mL syringes to manually push blood into the patient, a method that is fast and inexpensive but carries a high risk of red blood cell (RBC) destruction (hemolysis) due to shear stress.Pneumatic Pressure Bags: Applying 300 mmHg of external pressure to the blood bag, which may offer more controlled infusion but requires specialized equipment and may still carry hemolysis risks.Study ObjectivesThe primary objective is to compare the safety of these two methods by measuring the incidence of hemolysis through surrogate laboratory markers. Secondary objectives focus on clinical efficacy, including the speed of hemodynamic stabilization and overall patient outcomes.Methodology and InterventionParticipants are randomized in a 1:1 ratio using computer-generated sequences and sealed envelopes. All patients receive standardized vascular access consisting of two 18-gauge peripheral cannulae and one 16-gauge external jugular cannula.Group 1 (Manual Syringing): Blood is administered using 20 mL syringes.Group 2 (Pressure Bag): Blood is administered via pneumatic pressure bags set at a constant 300 mmHg.Due to the nature of the interventions, the clinical team and patients cannot be blinded. However, the study employs triple-blinding for the outcome assessors (laboratory personnel and data collectors) and the statistical analysts to minimize bias.Outcomes and Safety MonitoringThe study measures primary safety outcomes using Lactate Dehydrogenase (LDH) and indirect bilirubin levels taken at baseline and six hours post-transfusion. Hemodynamic stability is strictly defined as maintaining a systolic blood pressure $\ge90$ mmHg, a heart rate $\le100$ bpm, and oxygen saturation $\ge95\%$ for at least 30 minutes.To ensure participant safety, the protocol includes a mitigation strategy: if significant hemolysis is suspected, the transfusion will be halted immediately, and the patient will receive supportive care, including hydration and electrolyte monitoring.Sample Size and AnalysisThe study aims to enroll 50 participants (25 per group), which includes an over-sampling buffer from the calculated requirement of 44 total participants to maintain a 95% confidence level and 90% power. Data analysis will utilize independent t-tests or Mann-Whitney U tests for continuous variables and Chi-square or Fisher's exact tests for categorical outcomes

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Soudy Hammad, lecturer of anesthesia,SICU,
  • Phone Number: +201017446683 +201014761523
  • Email: soudi.salah@aswu.edu.eg

Study Contact Backup

Study Locations

  • Egypt
      • Aswān, Egypt
        • Recruiting
        • Aswan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18-45 years undergoing cesarean section
  • Diagnosed major obstetric hemorrhage (blood loss ≥1000 mL or hemodynamic instability requiring transfusion)
  • Written informed consent for participation

Exclusion Criteria:

  • Pre-existing hemolytic conditions (e.g., sickle cell disease, thalassemia)
  • Known hypersensitivity to blood products
  • Severe baseline coagulopathy (defined as INR > 2.0 or Platelet count < 50,000/mm³) or established disseminated intravascular coagulation (DIC) prior to randomization
  • Refusal to receive blood transfusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Syringing with 20 mL Syringes.
Participants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae
Device: Manual syringing
Participants in this arm receive blood products administered manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae
Experimental: Blood transfusion via pneumatic pressure bags set at 300 mmHg
Participants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae
Device: pneumatic pressure bag
Participants in this arm receive blood products administered using a pneumatic pressure bag inflated to a constant 300 mmHg through 18-gauge peripheral and 16-gauge external jugular cannulae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemolysis incidence evaluated using surrogate markers
Time Frame: From enrollment to the end of treatment at 6 hours post transfusion

The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers:

1. Lactate Dehydrogenase (LDH) levels,
From enrollment to the end of treatment at 6 hours post transfusion
Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels
Time Frame: From enrollment until 6 hours post operative

The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers:

2. Indirect bilirubin levels
From enrollment until 6 hours post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of hemodynamic stability
Time Frame: From enrollment to the end of treatment at 6 hours post transfusion
Achievement of hemodynamic stability in patients undergoing cesarean section complicated by major obstetric hemorrhage, comparing manual syringe transfusion versus pneumatic pressure bag transfusion. Hemodynamic stability is defined as the sustained achievement of the following for at least 30 minutes: Systolic blood pressure (BP) ≥90 mmHg, Heart rate ≤100 beats per minute (bpm), Oxygen saturation ≥95%.
From enrollment to the end of treatment at 6 hours post transfusion
Total volume of blood products administered
Time Frame: From enrollment to the end of treatment at 6 hours post transfusion
Total volume of blood products administered
From enrollment to the end of treatment at 6 hours post transfusion
Transfusion-related complications
Time Frame: From enrollment to the end of treatment at 6 hours post transfusion

Transfusion-related complications such as:

  • Acute kidney injury,
  • Transfusion reactions
From enrollment to the end of treatment at 6 hours post transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University

Investigators

  • Study Chair: Mohammed Saeed, lecturer, Aswan University-Faculty of Medicine-New Aswan City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1127/7/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared for the following reasons:

Privacy and Confidentiality: The study involves sensitive maternal health data, and the current protocol is designed to restrict data access strictly to the primary research team to ensure participant anonymity.

Institutional Policy: In accordance with the standards of Aswan University Hospital, data is stored in secure, password-protected databases with access limited to authorized investigators only.

Ethical Constraints: The informed consent signed by participants specifies that their data will be used solely for the purposes of this specific research study and will not be made available for secondary use by outside researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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