Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
研究概览
简要总结
Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.
The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants.
The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smoking mother
- •healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
- •normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
- •single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
- •expected vaginal delivery with cephalic presentation
- •mother should be able to master Swedish well enough to participate in the study
- •mother should live close enough to the hospital to be ready to return for follow up after four months.
排除标准
- •Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
结局指标
主要结局
Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
时间窗: 4 months of age (plus or minus three weeks)
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status
次要结局
- Are the rates of successful umbilical arterial samples equal between the groups?(Immediately after birth (within 30 seconds))
- Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?(4 months of age (plus or minus three weeks))
- Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?(4 months of age (plus or minus three weeks))
- Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?(Mean 2 to 3 days of age (within 48-96 hours after birth))
- Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?(12 months of age (plus or minus one month))
- Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?(Within 7 days after birth)
- Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?(After giving birth until discharge from maternity ward)
- Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?(12 months of age (plus or minus one month))
- Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?(Mean 2 to 3 days of age (within 48-96 hours after birth))
- Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?(12 months of age (plus or minus one month))
- Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?(Within 6 hours after birth)