Comparison of two techniques for collecting umbilical cord blood: on the mother (upper level) versus on the delivery table (bottom level)

Completed

• Conditions: mbilical cord blood collection; Pregnancy and Childbirth; Umbilical cord blood collection

• Registration Number: ISRCTN65689096
• Lead Sponsor: Hospital Donostia (Osakidetza) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

1. Term pregnancy
2. Low-risk vaginal delivery
3. Unique newborn
4. Maternal age greater than 18 years

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight of cord blood units, quantitative variable, measured in mg. Outcomes will be measured simultaneously with the intervention.

Secondary Outcome Measures

Name	Time	Method
Validity of the unit and storage. Validity criteria are considered: <br>1. If the count is 1.5 x 10^9 TNC unit is accepted<br>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<br><br>Outcomes will be measured simultaneously with the intervention.