Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants at Birth and Three Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Hematological Characteristics of Infants
研究概览
简要总结
In developing countries up to 50% of children become anemic by 12 months of age(1. Iron deficiency anemia is a major risk factor for neonatal and infantile mortality and morbidity in Pakistan. It has detrimental effects on neurodevelopment of infants and may be irreversible even after iron therapy(2). Type of cost effective interventions during perinatal period for prevention of anemia in later infancy is limited. Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth(3. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally(4) Paucity of national guidelines and lack of substantial data in Pakistan on this topic strongly necessitates such study trials. This study may contribute to develop a protocol on the timing of cord clamping which will be cost effective in prevention of iron deficiency anemia in the investigators infantile population.
The investigators will conduct a randomized controlled trial and the investigators hypothesis is that delayed cord clamping will result in higher hemoglobin (Hb), hematocrit (Hct) and ferritin at third month as compared to early cord clamping.
OBJECTIVES:
A- Primary:
- To study the effect of timing of umbilical cord clamping on hemoglobin (Hb), Hematocrit (Hct) at birth, 48 hours and Hb, Hct and ferritin at three months of age.
- To study the effect of timing of umbilical cord clamping on short term clinical profile of neonates like jaundice, respiratory distress, anemia, polycythemia etc. during fist 24 to 48 hours of life.
B- Secondary:
To assess whether delayed cord clamping is associated with undesirable effects on mothers followed till 48 hours postpartum.
详细描述
Delayed umbilical cord clamping (DCC) results in approximately 30-40 ml additional placental blood volume transfusion to the neonate and 30-35 mg increase in iron stores at birth(5).The neonatal benefits include higher hematocrit (Hct), higher red blood cells flow to vital organs, better cardiopulmonary adaptation, additional iron stores and less anemia in later infancy(6).It is evident from different studies that no adverse effects of DCC have been noticed in mothers as well as in their neonates(7). The beneficial effect of delayed cord clamping is not only observed in term infants but it has a positive impact on preterm and small for gestational age (SGA) infants too. The requirement of packed cell transfusion in first six months has significantly reduced as noticed from different studies(8).It is also associated with lower risk of intraventricular hemorrhage and late onset sepsis in preterm infants(9).
The practice of early cord clamping (ECC) is commonly following in our maternity units. It is believed that it reduces the risk of post partum haemorrhage (PPH) and duration of third stage of labour. But at the same time it does not provide any benefit to the neonate(4).Conversely it increases the possibility of fetomaternal transfusion, hypovolemic damage, neonatal anemia, respiratory distress syndrome and type 2 diabetes in later life(5).The risk of iso immunization in rhesus negative mothers are also increased with ECC(10).
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
- 1 Minute 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother-infant pairs, between 35 weeks and 41 completed weeks of pregnancy, planned to deliver through vaginal or Elective lower segment cesarean section(ELSCS)
排除标准
- •Women with multiple gestation
- •Complications like pregnancy induced hypertension (PIH), Gestational diabetes Mellitus (GDM), Pre/Eclampsia, placental insufficiency, suboptimal CTG (late deceleration, variable deceleration)
- •Rh-isoimmunization
- •Chronic maternal illnesses (hypertension, cardiomyopathies, chronic renal diseases, haemoglobinopathies
- •Pre-existing risk factor for postpartum haemorrhage, like polyhydramnios, previous PPH
- •Infants with antenatal diagnosis of congenital malformations of any system (CVS, GIT, RENAL CNS ,RESP), anomalies or syndromes
- •Emergency caesarean section (EmLSCS)
- •Need for neonatal resuscitation at birth and NICU admission due to causes not directly related to the intervention trial.
- •Criteria 1 to 6 will be applied before randomization and criteria 7 and 8 assess after randomization.
结局指标
主要结局
Hematological Characteristics of Infants
时间窗: From Birth to Third month of age
Infantile hematological characteristics ( hemoglobin, hematocrit at birth(cord),48 hours of age and Hemoglobin, Hematocrit and serum ferritin at third month).
Short term Clinical Profiles
时间窗: From birth to 48 hours of age
Short term neonatal clinical profile (respiratory distress, polycythemia hematocrit ≥65%), neonatal anemia , clinical jaundice hyperbilirubinemia),requirement of phototherapy or exchange transfusion)
次要结局
- Maternal Characteristics(From Delivery to 48 hours postpartum)
研究者
Dr Zulfiqar Ahmed Bhutta
Professor and Founding Chair, Division of Women and Child Health
Aga Khan University