ISRCTN65689096已完成不适用
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
Hospital Donostia (Osakidetza) (Spain)0 个研究点目标入组 44 人开始时间: 2010年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Term pregnancy
- •2. Low-risk vaginal delivery
- •3. Unique newborn
- •4. Maternal age greater than 18 years
排除标准
- •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
研究者
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