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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment in Late Pre-term and Term Infants; a Facility-based Randomized-controlled Trial in Nepal

Brief 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.

Detailed Summary:

Study Protocol Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based randomized-controlled trial in Nepal

Introduction At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. This task takes place during the third stage of labour, which is the period of time from the birth of the infant to the delivery of the placenta.

Active management of the third stage of labour has been described in a recent World Health Organization (WHO) report as the "cornerstone" of obstetric and midwifery practice during the latter part of the 20th century. Active management has involved the clinician intervening in the process through three interrelated processes: the administration of an uterotonic drug; early cord clamping and cutting; and controlled traction of the umbilical cord.

Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. Due to evidence shown the last decade, recent guidelines for management of the third stage of labour no longer recommend immediate cord clamping but changes in practice is questioned and policies on hospitals are rare.

Possible beneficial and adverse effects:

Delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth. This placental transfusion can provide the infant with an additional 40% more blood volume. The amount of blood returned to the infant depends on when the cord is clamped
Sponsor: Uppsala University

Current Primary Outcome: Hemoglobin [ Time Frame: 8 months plus/minus one month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Hemoglobin [ Time Frame: 12 months plus/minus one month ]
  Hemoglobin will be analyzed be comparing means and as a categorical variable, defining anemia as Hemoglobin < 110 g/L
• Ferritin [ Time Frame: 8 months plus/minus one month ]
  Ferritin will be analyzed be comparing means and as a categorical variable, defining iron deficiency as Ferritin < 12 μg/L
• Ferritin [ Time Frame: 12 months plus/minus one month ]
  Ferritin will be analyzed be comparing means and as a categorical variable, defining iron deficiency as Ferritin < 12 μg/L
• Iron deficiency anemia [ Time Frame: 8 months plus/minus one month ]
  Defining iron deficiency as a combination of Hemoglobin < 110 g/L and Ferritin < 12 μg/L
• Iron deficiency anemia [ Time Frame: 12 months plus/minus one month ]
  Defining iron deficiency as a combination of Hemoglobin < 110 g/L and Ferritin < 12 μg/L
• Bilirubin [ Time Frame: 2 days ]
  Measured by a transcutaneous method.
• Psychomotor development assessed by the Ages and Stages Questionnaire. [ Time Frame: 12 months ]
  Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 48-month questionnaire will be assessed.
• Psychomotor development assessed by Bayley Scales of Infant and Toddler Development 3rd ed. (Bayley III) [ Time Frame: 18 months plus 6 months ]

Original Secondary Outcome: Same as current

Information By: Uppsala University

Dates:
Date Received: August 19, 2014
Date Started: October 2014
Date Completion: March 2017
Last Updated: February 21, 2017
Last Verified: February 2017