Effect of Umbilical Cord Management(UCM) Protocol on Hematological Profile of Babies Born Through Lower Segment Caesarean Section (LSCS) At Discharge-An Open Label Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To study the effect of UCM protocol on hematological profile (Hb & Hct) at discharge of all eligible newborn babies delivered by LSCS.
研究概览
简要总结
Study includes consequent eligible mother-infant dyad delivered at LSCS at CHEC, Kolkata. After getting a written informed consent from parents posted for LSCS, mother will be randomized to either of study arms. Babies born to mothers randomized to intervention arm will be given UCM protocol/ 3 x milking procedure will be carried out from placenta towards baby involving at least 25cm umbilical cord length. Umbilical cord will be clamped after 60 seconds. Babies randomized to control arm will have cord clamping done at 60 seconds without milking following standard protocol of delayed cord clamping (DCC) as per WHO. All babies will be investigated for Hb and PCV at 72 hours or discharge (whichever is earlier), sampling will be combined with discharge bilirubin, blood group, G6PD and TSH screening protocol of institute.
All babies will be followed up till 16 weeks for secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 4.00 Month(s)（—）
- 性别
- All
入选标准
- •All neonates born at >34 weeks periods of gestation through LSCS at Command Hospital (EC) Kolkata during study period.
排除标准
- •Babies born with: 1.Perinatal Asphyxia 2.Multifoetal pregnancy 3.Babies having congenital anomalies 4.Anticipated fetal anemia, 5.Category III cardiotocography tracing.
结局指标
主要结局
To study the effect of UCM protocol on hematological profile (Hb & Hct) at discharge of all eligible newborn babies delivered by LSCS.
时间窗: 72 hours of birth/ discharge
次要结局
- To find effect of UCM protocol on:(1.Significant Neonatal Hyperbilirubinemia (Requiring phototherapy))