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
  Purpose

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.


Condition Intervention Phase
Anemia
Ferritin
Complications
Hemorrhage
Jaundice
Procedure: Early Cord Clamping
Procedure: Delayed Cord Clamping
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants at Birth and Three Months of Age

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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).


Enrollment: 340
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Cord Clamping Group
Early Cord Clamping Group (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate).
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
Experimental: Delayed Cord Clapming Group
Delayed Umbilical Cord Clamping Group (Clamping of Umbilical Cord within 2 minutes of shoulder delivery of neonate).
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

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).

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081977

Locations
Pakistan
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
Investigators
Study Director: Dr Zulfiqar Bhutta, MBBS, PhD The Aga Khan University
Principal Investigator: Dr Huma Shaireen, MBBS, FCPS The Aga Khan University
  More Information

No publications provided

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT01081977     History of Changes
Other Study ID Numbers: 991-Ped/ERC-08
Study First Received: March 4, 2010
Last Updated: August 1, 2012
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Delayed cord clamping
Ferritin
Hemoglobin
Neonatal anemia
Postpartum haemorrhage
Neonatal jaundice

Additional relevant MeSH terms:
Anemia
Hemorrhage
Jaundice
Hematologic Diseases
Pathologic Processes
Hyperbilirubinemia
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014