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
| NCT ID | NCT07466719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aswan University |
| Condition | Obstetric Hemostasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Mohammed Saeed, lecturer
STUDY CHAIR
Aswan University-Faculty of Medicine-New Aswan City
Frequently Asked Questions
Who can join the NCT07466719 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Obstetric Hemostasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07466719 currently recruiting?
Yes, NCT07466719 is actively recruiting participants. Contact the research team at soudi.salah@aswu.edu.eg for enrollment information.
Where is the NCT07466719 trial being conducted?
This trial is being conducted at Aswān, Egypt.
Who is sponsoring the NCT07466719 clinical trial?
NCT07466719 is sponsored by Aswan University. The principal investigator is Mohammed Saeed, lecturer at Aswan University-Faculty of Medicine-New Aswan City. The trial plans to enroll 50 participants.