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

NCT01081977 | Completed Phase 2 DMC

• 1 other identifier: 991-Ped/ERC-08
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Anemia; Ferritin; Complications; Hemorrhage; Jaundice

Keywords

Delayed cord clamping; Ferritin; Hemoglobin; Neonatal anemia; Postpartum haemorrhage; Neonatal jaundice

Outcome Measures

Primary Outcomes (2)

• Hematological Characteristics of Infants

  Infantile hematological characteristics ( hemoglobin, hematocrit at birth(cord),48 hours of age and Hemoglobin, Hematocrit and serum ferritin at third month).

  From Birth to Third month of age

• Short term Clinical Profiles

  Short term neonatal clinical profile (respiratory distress, polycythemia hematocrit ≥65%), neonatal anemia , clinical jaundice hyperbilirubinemia),requirement of phototherapy or exchange transfusion)

  From birth to 48 hours of age

Secondary Outcomes (1)

• Maternal Characteristics

  From Delivery to 48 hours postpartum

Study Arms (2)

Early Cord Clamping Group

ACTIVE COMPARATOR

Early Cord Clamping Group (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate).

Procedure: Early Cord Clamping

Delayed Cord Clapming Group

EXPERIMENTAL

Delayed Umbilical Cord Clamping Group (Clamping of Umbilical Cord within 2 minutes of shoulder delivery of neonate).

Procedure: Delayed Cord Clamping

Interventions

Early Cord Clamping PROCEDURE

Early Umbilical Cord Clamping (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate)

Also known as: Cord clamping, Neonate, Anemia

Early Cord Clamping Group

Delayed Cord Clamping PROCEDURE

Delayed Umbilical Cord Clamping (Clamping Umbilical Cord after 2 minutes of shoulder delivery of neonate

Also known as: Cord clamping, Ferritin, Infant

Delayed Cord Clapming Group

Eligibility Criteria

• Age: 1 Minute - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 75300, Pakistan

Location

Related Publications (1)

• 1. World Health Organozation. Newborns: No longer going unnoticed. The World Health Report:2005.p 79-101. . 2005 [updated 2005; cited]; Available from: http://www.who.int/whr/2005/en/. 2. Shafir T, Angulo-Barroso R, Jing Y, Angelilli ML, Jacobson SW, Lozoff B. Iron deficiency and infant motor development. Early Hum Dev. 2008 Jul;84(7):479-85. 3. Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. 4. Ononeze AB, Hutchon DJ. Attitude of obstetricians towards delayed cord clamping: a questionnaire-based study. J Obstet Gynaecol. 2009 Apr;29(3):223-4. 5. Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, et al. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. 6. Zaramella P, Freato F, Quaresima V, Secchieri S, Milan A, Grisafi D, et al. Early versus late cord clamping: effects on peripheral blood flow and cardiac function in term infants. Early Hum Dev. 2008 Mar;84(3):195-200. 7. McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008(2):CD004074. 8. Strauss RG, Mock DM, Johnson KJ, Cress GA, Burmeister LF, Zimmerman MB, et al. A randomized clinical trial comparing immediate versus delayed clamping of the umbilical cord in preterm infants: short-term clinical and laboratory endpoints. Transfusion. 2008 Apr;48(4):658-65. 9. Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. 10. Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7.

  BACKGROUND

MeSH Terms

Conditions

Anemia; Hemorrhage; Jaundice; Anemia, Neonatal; Postpartum Hemorrhage; Jaundice, Neonatal

Interventions

Umbilical Cord Clamping; Ferritins

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia; Skin Manifestations; Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hyperbilirubinemia, Neonatal

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Metalloproteins

Study Officials

• Dr Zulfiqar Bhutta, MBBS, PhD

  Aga Khan University

  STUDY DIRECTOR

• Dr Huma Shaireen, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Founding Chair, Division of Women and Child Health

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

PA (1)