Vaginal deliveries and caesarean sections Pregnancy and Childbirth
Conditions
Interventions
Consenting and collecting participants' samples
Consent will be sought from women scheduled that are about to have a caesarean section or go through assisted vaginal delivery. Collecti
Sponsors
HemoClear B.V.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women giving assisted vaginal birth or undergoing caesarean section. 2. Women losing between 500 and 1500 mL of shed blood
Exclusion criteria
Exclusion criteria: 1. Any patient undergoing caesarean section where cell salvage is clinically indicated and standard practice at West Middlesex University Hospital (i.e. placenta praevia major, the patient is a Jehovah’s Witness etc) 2. Any patients with significant haemoglobinopathy (such as sickle-cell or thalassaemia) where red cell fragility may be an issue 3. Any patients taking intrapartum antibiotics 4. Any patient with an active diagnosis of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The novel HemoClear device's washing efficiency statistical comparability to the gold standard cell saver, measured using the statistical difference in the amounts of blood cells and non-cellular components after processing with HemoClear compared to processing with the gold standard device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of maternal blood cells recovered by each device measured by complete blood counts using a haematology analyser, prior to processing of the shed blood and after processing with each device 2. Percentage of neonatal blood cells recovered by each device measured using the Kleihauer-Betke tests, prior to processing of the shed blood and after processing with each device 3. Percentage of alpha-fetoprotein washed out by each device as a marker of amniotic fluid content measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 4. Percentage of bacterial load washed out by each device measured using a microbial detection system, prior to processing of the shed blood and after processing with each device 5. Percentage of albumin washed out by each device as a general marker of washing efficiency and removal of proteins, measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 6. Percentage of lactate dehydrogenase washed out by each device as a market of the amount of dead red blood cells measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 7. Percentage of heparin washed out by each device as a marker of coagulation, measured using a coagulometer, prior to processing of the shed blood and after processing with each device 8. The effect on the coagulation profile of the blood cells by each device measured by activated partial thromboplastin time and prothrombin time using a coagulometer, prior to processing of the shed blood and after processing with each device | — |
Countries
England, United Kingdom
Outcome results
None listed