Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants
Condition: Anemia; Ferritin; Complications; Hemorrhage; Jaundice
MeSH terms: Hemorrhage; Jaundice
Study type: Interventional
Phase: Phase 2

Summary: 
      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:

        1. 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.

        2. 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.
    

Detailed description: 
      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).
    

Intervention name(s): Early Cord Clamping; Delayed Cord Clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): Early Umbilical Cord Clamping (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate); Delayed Umbilical Cord Clamping (Clamping Umbilical Cord after 2 minutes of shoulder delivery of neonate
Other intervention name(s): Cord clamping; Neonate; Anemia; Cord clamping; Ferritin; Infant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Delayed cord clamping; Ferritin; Hemoglobin; Neonatal anemia; Postpartum haemorrhage; Neonatal jaundice