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

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.

Conditions

• Anemia
• Ferritin
• Complications
• Hemorrhage
• Jaundice

Interventions

PROCEDURE

Early Cord Clamping

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

PROCEDURE

Delayed Cord Clamping

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

Sponsors & Collaborators

• Aga Khan University

  lead OTHER

Principal Investigators

• Dr Zulfiqar Bhutta, MBBS, PhD · Aga Khan University

• Dr Huma Shaireen, MBBS, FCPS · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2010-03-31

Completion

2010-04-30

Countries

• Pakistan

Study Locations