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Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01081977
First received: March 4, 2010
Last updated: August 1, 2012
Last verified: August 2012

March 4, 2010
August 1, 2012
August 2008
March 2010   (final data collection date for primary outcome measure)
  • Hematological Characteristics of Infants [ Time Frame: From Birth to Third month of age ] [ Designated as safety issue: No ]
    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 [ Time Frame: From birth to 48 hours of age ] [ Designated as safety issue: Yes ]
    Short term neonatal clinical profile (respiratory distress, polycythemia hematocrit ≥65%), neonatal anemia , clinical jaundice hyperbilirubinemia),requirement of phototherapy or exchange transfusion)
Same as current
Complete list of historical versions of study NCT01081977 on ClinicalTrials.gov Archive Site
Maternal Characteristics [ Time Frame: From Delivery to 48 hours postpartum ] [ Designated as safety issue: Yes ]
Maternal characteristics ( Primary PPH, duration of third stage of labour ≥ 30 min, mean blood loss during the third stage of labour, need for therapeutic oxytocin, manual removal of placenta and Hb at 48 hours postpartum).
Same as current
Not Provided
Not Provided
 
Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants
Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants at Birth and Three Months of Age

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Anemia
  • Ferritin
  • Complications
  • Hemorrhage
  • Jaundice
  • Procedure: Early Cord Clamping
    Early Umbilical Cord Clamping (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate)
    Other Names:
    • Cord clamping
    • Neonate
    • Anemia
  • Procedure: Delayed Cord Clamping
    Delayed Umbilical Cord Clamping (Clamping Umbilical Cord after 2 minutes of shoulder delivery of neonate
    Other Names:
    • Cord clamping
    • Ferritin
    • Infant
  • Active Comparator: Early Cord Clamping Group
    Early Cord Clamping Group (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate).
    Intervention: Procedure: Early Cord Clamping
  • Experimental: Delayed Cord Clapming Group
    Delayed Umbilical Cord Clamping Group (Clamping of Umbilical Cord within 2 minutes of shoulder delivery of neonate).
    Intervention: Procedure: Delayed Cord Clamping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
April 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mother-infant pairs, between 35 weeks and 41 completed weeks of pregnancy, planned to deliver through vaginal or Elective lower segment cesarean section(ELSCS)

Exclusion Criteria:

  • 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.

Both
up to 3 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01081977
991-Ped/ERC-08
Yes
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
Aga Khan University
Not Provided
Study Director: Dr Zulfiqar Bhutta, MBBS, PhD The Aga Khan University
Principal Investigator: Dr Huma Shaireen, MBBS, FCPS The Aga Khan University
Aga Khan University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP