Manual syringe versus pneumatic pressure bag for emergency blood transfusion during cesarean hemorrhage
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
Run by Aswan University · NCT07466719 · Data updated 2026-11-12
This trial will test whether using manual 20 mL syringes or a pneumatic pressure bag (300 mmHg) gives safer, faster blood transfusions for women having a cesarean section who develop major obstetric bleeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Aswan University Academic / other |
| Locations | 1 site (Aswān) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | April 1, 2026 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07466719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 undergoing cesarean section who develop major obstetric hemorrhage (≥1000 mL blood loss or hemodynamic instability) and who consent to transfusion are the ideal candidates.
✕Probably not a fit
Patients with pre-existing hemolytic diseases, severe baseline coagulopathy, those who refuse blood transfusion, or patients not undergoing cesarean delivery are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, randomized controlled trial at Aswan University Hospital comparing two rapid transfusion techniques used during major obstetric hemorrhage in cesarean deliveries. Participants who meet criteria for major bleeding will be randomized to receive blood either via manual syringing (20 mL syringes) or via a pneumatic pressure bag inflated to 300 mmHg. The primary safety endpoint is incidence of hemolysis; secondary endpoints include time to hemodynamic stability, total blood product use, transfusion-related complications, and hospital length of stay. The trial excludes patients with pre-existing hemolytic disorders, severe coagulopathy, or those who refuse transfusion.
Why it matters
Potential benefit: If successful, the trial could identify a safer and faster transfusion method that reduces red blood cell destruction and improves stabilization for women with life-threatening obstetric bleeding.
How similar studies have gone: Direct randomized comparisons of these two transfusion techniques are scarce; observational and laboratory data suggest manual syringing can increase hemolysis but robust clinical evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Aswan University Hospital
Aswān, Egypt Recruiting
Study contacts
- Study coordinator: Soudy Hammad, lecturer of anesthesia,SICU,
- Email: soudi.salah@aswu.edu.eg
- Phone: +201014761523
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.