An interventional study of Manual syringing and pneumatic pressure bag in Obstetric Hemostasis, Intravascular Hemolysis and Major Obstetric Hemorrhage, sponsored by Aswan University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Aswan University · Not applicable, Interventional, and Treatment
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
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
120 studies on the registry are indexed under Hemolysis; 22 are open to participants now.
This study's planned enrollment of 50 is close to the median of 49 across 78 interventional studies indexed under Hemolysis.
Browse Hemolysis studies →Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 manually by clinical staff using 20 mL syringes through 18-gauge peripheral and 16-gauge external jugular cannulae
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
Hemolysis incidence evaluated using surrogate markers
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers: 1\. Lactate Dehydrogenase (LDH) levels,
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels
The primary outcome of this study is Hemolysis incidence evaluated using surrogate markers: 2\. Indirect bilirubin levels
Time frame: From enrollment until 6 hours post operative
Achievement of hemodynamic stability
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%.
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Total volume of blood products administered
Total volume of blood products administered
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Transfusion-related complications
Transfusion-related complications such as: * Acute kidney injury, * Transfusion reactions
Time frame: From enrollment to the end of treatment at 6 hours post transfusion
Plan to share: No — 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
Started Sep 2025 (actual). Primary completion is estimated for Apr 2026, 7 months after the start.
Of 28 interventional studies with no phase under Hemolysis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's planned 7 months is below that.
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