Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment

Summary

The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development is evaluated by questionnaire (Ages \& Stages Questionnaire ) at 12 months of age, and by testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a high proportion of anemia at one year of age (about 75%), we can reduce the number of children in the study and still achieve significant results.

Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in children. Anemia is estimated by WHO to occur among 25% of all children before school age, and the corresponding figure in Europe is 3-9 %.

By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume remaining in the placenta is transfused over to the child's body. Research shows that the neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months' supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could reduce iron deficiency in children at four months of age by 90%. Globally, most countries practice early cord clamping and the child is deprived of the placental blood transfusion. The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens development.

The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It hosts approximately 23,000 births annually.

Conditions

• Anemia
• Iron Deficiency
• Neonatal Jaundice

Interventions

PROCEDURE

Early (≤30 seconds) cord clamping

Early (≤30 seconds) cord clamping of the umbilical cord after delivery.

PROCEDURE

Delayed (≤180 seconds) cord clamping

Delayed (≤180 seconds) cord clamping of the umbilical cord after delivery.

Sponsors & Collaborators

• UNICEF

  collaborator OTHER

• Ministry of Health and Population, Nepal

  collaborator OTHER_GOV

• The Swedish Society of Medicine

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Ola Andersson, MD PhD · Uppsala University

• Ashish KC, MD · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

34 Weeks

Max Age

41 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2014-12-31

Completion

2015-12-11

Countries

• Nepal

Study Locations