RecruitingNot Applicable

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

Egypt50 participantsStarted 2025-09-01

Plain-language summary

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

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemolysis incidence evaluated using surrogate markers

Timeframe: From enrollment to the end of treatment at 6 hours post transfusion

Hemolysis incidence evaluated using surrogate markers: Indirect bilirubin levels

Timeframe: From enrollment until 6 hours post operative

Trial details

NCT IDNCT07466719

SponsorAswan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Soudy Hammad, lecturer of anesthesia,SICU,

+201014761523 soudi.salah@aswu.edu.eg

View on ClinicalTrials.gov More Obstetric Hemostasis trials