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

NCT02222805 | Completed

• 1 other identifier: CCANEMIA11
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Iron Deficiency; Neonatal Jaundice

Keywords

Cord clamping; Iron deficiency; Anemia; Iron; Hyperbilirubinemia; Jaundice; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• Hemoglobin

  Hemoglobin will be analyzed be comparing means and as a categorical variable, defining anemia as Hemoglobin \< 110 g/L

  8 months plus/minus one month

Secondary Outcomes (8)

• Hemoglobin

  12 months plus/minus one month

• Ferritin

  8 months plus/minus one month

• Ferritin

  12 months plus/minus one month

• Iron deficiency anemia

  8 months plus/minus one month

• Iron deficiency anemia

  12 months plus/minus one month

Study Arms (2)

Early cord clamping (ECC)

OTHER

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

Procedure: Early (≤30 seconds) cord clamping

Delayed cord clamping (DCC)

OTHER

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

Procedure: Delayed (≤180 seconds) cord clamping

Interventions

Early (≤30 seconds) cord clamping PROCEDURE

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

Also known as: Immediate cord clamping

Early cord clamping (ECC)

Delayed (≤180 seconds) cord clamping PROCEDURE

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

Also known as: Late cord clamping, Deferred cord clamping, Optimal cord clamping

Delayed cord clamping (DCC)

Eligibility Criteria

• Age: 34 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Late preterm or term pregnancy (gestational age 34 to 41 weeks)
• Vaginal delivery

You may not qualify if:

• Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

Sponsors & Collaborators

• Uppsala University: lead
• UNICEF: collaborator
• Ministry of Health and Population, Nepal: collaborator
• The Swedish Society of Medicine: collaborator

Study Sites (1)

Paropakar Maternity and Women's Hospital

Kathmandu, 44600, Nepal

Location

Related Publications (7)

• Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.

  PMID: 22089242 BACKGROUND

• Andersson O, Domellof M, Andersson D, Hellstrom-Westas L. Effect of delayed vs early umbilical cord clamping on iron status and neurodevelopment at age 12 months: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):547-54. doi: 10.1001/jamapediatrics.2013.4639.

  PMID: 24756128 BACKGROUND

• Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.

  PMID: 28114607 RESULT

• Rana N, Kc A, Malqvist M, Subedi K, Andersson O. Effect of Delayed Cord Clamping of Term Babies on Neurodevelopment at 12 Months: A Randomized Controlled Trial. Neonatology. 2019;115(1):36-42. doi: 10.1159/000491994. Epub 2018 Oct 2.

  PMID: 30278462 RESULT

• Rana N, Ranneberg LJ, Malqvist M, Kc A, Andersson O. Delayed cord clamping was not associated with an increased risk of hyperbilirubinaemia on the day of birth or jaundice in the first 4 weeks. Acta Paediatr. 2020 Jan;109(1):71-77. doi: 10.1111/apa.14913. Epub 2019 Jul 15.

  PMID: 31240753 RESULT

• Berg JHM, Isacson M, Basnet O, Gurung R, Subedi K, Kc A, Andersson O. Effect of Delayed Cord Clamping on Neurodevelopment at 3 Years: A Randomized Controlled Trial. Neonatology. 2021;118(3):282-288. doi: 10.1159/000515838. Epub 2021 May 7.

  PMID: 33965945 DERIVED

• Kc A, Malqvist M, Rana N, Ranneberg LJ, Andersson O. 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. BMC Pediatr. 2016 Mar 10;16:35. doi: 10.1186/s12887-016-0576-z.

  PMID: 26965317 DERIVED

MeSH Terms

Conditions

Anemia; Iron Deficiencies; Jaundice, Neonatal; Hyperbilirubinemia; Jaundice

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ola Andersson, MD PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Ashish KC, MD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 11, 2015
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)