Comparison of two techniques for collecting umbilical cord blood: on the mother (upper level) versus on the delivery table (bottom level)
| ISRCTN | ISRCTN65689096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65689096 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/10/2010
- Registration date
- 09/11/2010
- Last edited
- 09/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Iratxe Urreta
Scientific
Scientific
Balleneros 6-3 D
San Sebastian
20011
Spain
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled clinical trial of the comparison of two techniques of umbilical cord blood collection (from mother versus on delivery table) on women with term pregnancy with low-risk vaginal delivery and a unique newborn |
| Study objectives | The collection of umbilical cord blood (UCB) clamped on the mother is more effective since it achieves a greater amount and cellularity of UCB units with no increase in cross-clamping time compared to clamping on the delivery table. |
| Ethics approval(s) | Clinical Research Ethics Committee of Guipuzcoa Health Area approved on the 21st June 2010 (ref: 6/10) |
| Health condition(s) or problem(s) studied | Umbilical cord blood collection |
| Intervention | Control group: Clamping and cutting the umbilical cord blood on lower level about introitus, placing the newborn at delivery table (the table is about 80 cm from the introitus of the mother). Experimental group: Clamping and cutting the umbilical cord blood on upper level on the mother's abdomen. Measured at collection after delivery; no follow up. |
| Intervention type | Other |
| Primary outcome measure | Weight of cord blood units, quantitative variable, measured in mg. Outcomes will be measured simultaneously with the intervention. |
| Secondary outcome measures | Validity of the unit and storage. Validity criteria are considered: 1. If the count is 1.5 x 10^9 TNC unit is accepted 2. If the count is between 1.2 and 1.5 x 10^9, CNT is performed CD34 count, if this is greater than 4 x 10^6 units is accepted Outcomes will be measured simultaneously with the intervention. |
| Overall study start date | 01/12/2010 |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 44 |
| Key inclusion criteria | 1. Term pregnancy 2. Low-risk vaginal delivery 3. Unique newborn 4. Maternal age greater than 18 years |
| Key exclusion criteria | 1. Maternal age less than 18 years 2. Mental instability, intoxication by alcohol or narcotics 3. Have or have had: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-lymphotropic virus type I and II (HTLV I/II), babesiosis, kala-azar, and Chagas disease 4. Exposure to the risk of a transmissible infection: 4.1. For transfusion: Ineligible for six months (or for four months, if the screening test for hepatitis C virus using genomic technology of nucleic acid-NAT-negative results). Exclusion of people with a history of being transfused in the UK or malaria-endemic countries, HTLV, Chagas disease, HIV. 4.2. Tattoo or piercing the skin or mucous membranes, in the last six months (value) 4.3. Acupuncture in the six months preceding the birth, except done with sterile needles and by a qualified professional 4.4. People at risk due to direct household contact or sexual intercourse with people suffering from hepatitis, in the last six months 4.5. Instrumental-flexible endoscopy. Examinations or treatments involving the use of central catheters have been placed for several days in the last six months. 4.6. Splash of blood or mucus needle injury in the last six months 4.7. Major surgery in the past six months 5. Drug: intravenous or intramuscular non-prescription, including steroid or hormonal treatment for increased fitness 6. People who practice or have practiced prostitution 7. Sexual behaviour: exclusion of persons whose conduct is at high risk of serious infectious diseases transmitted through blood and blood components. After the cessation of risky behavior should be excluded for 12 months minimum. 8. Persons under xenotransplantation (organs of other animal species) 9. Cancer: Presence or history of malignancy (except basal cell carcinoma from primary skin carcinoma in situ of the uterine cervix, and some primary cntral nervous system [CNS] tumours, to be properly evaluated) 10. Patients with congenital coagulation disorders treated with blood products of human origin (clotting factors), any deficit inherited granulocytes, platelets, leukocytes, and hereditary enzyme, thrombocytopenia, alterations in the white series, treatment with oral anticoagulants or hereditary spherocytosis 11. Risk of transmission of prion diseases: 11.1. People with a diagnosis or family history of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease 11.2. Receptors derived from human pituitary hormones (e.g., growth hormone), dura mater recipients, recipients of cornea, sclera or other eye tissue 11.3. People with a history of dementia or degenerative neurological diseases caused by viral infection or unknown 11.4. People with more than 12 months stay in the United Kingdom during the period 1980 - 1996 12. Exclude during and at least two weeks after complete clinical recovery of an infectious disease, except for infections that are listed below where the following criteria apply: 12.1. Brucellosis, two years after complete restoration 12.2. Osteomyelitis: two years after cure confirmed 12.3. Q-fever: two years after cure confirmed 12.4. Syphilis: one year after cure confirmed 12.5. Toxoplasmosis: six months after clinical recovery 12.6. Tuberculosis: two years after cure confirmed 12.7. Rheumatic fever: two years after the disappearance of symptoms, unless there is evidence of chronic heart condition 12.8. Flu-like condition in two weeks after symptoms disappear 12.9. Maternal fever above 38°C, two weeks after his disappearance 13. Diseases of unknown aetiology, e.g., Parkinson's disease, Multiple Sclerosis, Amyotrophic lateral sclerosis (ALS), Crohn's disease, ulcerative colitis, ischaemic colitis, pancreatitis, and autoimmune diseases or connective tissue (systemic lupus erythematosus, rheumatoid arthritis, etc.) 14. Diabetes (type I and II), diabetes insipidus, pituitary insufficiency, pituitary adenoma, thyroid adenoma, Graves disease, Hashimoto's thyroiditis, hyperparathyroidism, adrenal insufficiency, congenital adrenal hyperplasia, Cushing, hyperaldosteronism, pheochromocytoma, hyperlipaemic essential hyperthyroidism and hypothyroidism pharmacological treatment 15. Extensive psoriasis, bullous dermatitis, erythema nodosum, mycosis fungoides, Bechet's disease, dermatitis herpetiformis, Sezary disease, Recklinghausen, etc., 16. Viral pericarditis in the past six months 17. Vaccination: 17.1. Attenuated virus and bacteria: exclusion for four weeks 17.2. Virus, bacteria or rickettsiae inactivated or eliminated: no exclusion of healthy people 17.3. Toxoids: no exclusion of healthy people 17.4. Vaccines against hepatitis A or hepatitis B: no exclusion of healthy people not exposed (accidental puncture) 17.5. Rabies: no exclusion of healthy people not exposed. Be excluded for one year if the vaccine is administered after exposure. 17.6. Vaccination against tick-borne encephalitis: no exclusion of healthy people not exposed 18. Exclusion epidemiological situations 19. Malaria: 19.1. People who have lived in a swamp during the first five years of life are excluded three years after the return of last visit to the endemic area, as long as no symptoms. The exclusion period can be reduced to four months if an immunologic or genomic molecular test validated for diagnosis of malaria is negative. 19.2. People with a history of malaria, will be excluded for three years after discontinuation and absence of symptoms. Subsequently, these people may be admitted if a molecular or genomic immunoassay validated for diagnosis of malaria is negative. 19.3. People without symptoms who have visited endemic areas, are excluded for six months after leaving the endemic area, unless a molecular or genomic immunoassay validated for diagnosis of malaria is negative 19.4. People with a history of undiagnosed febrile illness during a visit to an endemic area or within six months, will be excluded for three years after the disappearance of symptoms. May be reduced to four months if an immunologic or genomic molecular test validated for diagnosis of malaria is negative. 19.5. West Nile Virus: exclusion for 28 days after leaving an area where cases are detected transmission to humans 20. Maternal history and/or paternal genetic disease known 21. Severe maternal anaemia (haemoglobin less than 10 g severe) 22. Duration of less than 37 weeks gestation 23. Presence of symptoms of infection in the newborn 24. Clinical signs of foetal-maternal haemorrhage 25. Neonatal weight less than 2500 g 26. APGAR less than 8 with a poor outcome after 10 minutes 27. Signs of meconium aspiration by the infant 28. Maternal fever above 38°C during labour 29. Maternal hypertension 30. In pregnancies resulting from donated eggs or sperm, the donation will be excluded unless the genetic history of biological parents was obtained and documented 31. The administration of anti-D in the last 12 months is not grounds for exclusion, but must register 32. Disease with limited delivery of the extraction procedure 33. The relevant conditions existing in the parents and siblings should be reviewed |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Balleneros 6-3 D
San Sebastian
20011
Spain
20011
Spain
Sponsor information
Hospital Donostia (Osakidetza) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Pº Doctor Beguiristain s/n
San sebastian
20014
Spain
| Website | http://www.osakidetza.euskadi.net |
|---|---|
"ROR" |
https://ror.org/04fkwzm96 |
Funders
Funder type
Hospital/treatment centre
Hospital Donostia (Osakidetza) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
