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Trial record 49 of 107 for:    ( Map: Nepal )

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

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ClinicalTrials.gov Identifier: NCT02222805
Recruitment Status : Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
UNICEF
Ministry of Health and Population, Nepal
The Swedish Society of Medicine
Information provided by (Responsible Party):
Uppsala University

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.


Condition or disease Intervention/treatment Phase
Anemia Iron Deficiency Neonatal Jaundice Procedure: Early (≤30 seconds) cord clamping Procedure: Delayed (≤180 seconds) cord clamping Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Early cord clamping (ECC)
Early (≤30 seconds) cord clamping of the umbilical cord after delivery.
Procedure: Early (≤30 seconds) cord clamping
Early (≤30 seconds) cord clamping of the umbilical cord after delivery.
Other Name: Immediate cord clamping

Delayed cord clamping (DCC)
Delayed (≤180 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.
Other Names:
  • Late cord clamping
  • Deferred cord clamping
  • Optimal cord clamping




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: 8 months plus/minus one month ]
    Hemoglobin will be analyzed be comparing means and as a categorical variable, defining anemia as Hemoglobin < 110 g/L


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Bilirubin [ Time Frame: 2 days ]
    Measured by a transcutaneous method.

  7. 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.

  8. Psychomotor development assessed by Bayley Scales of Infant and Toddler Development 3rd ed. (Bayley III) [ Time Frame: 18 months plus 6 months ]


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Ages Eligible for Study:   34 Weeks to 41 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222805


Locations
Nepal
Paropakar Maternity and Women's Hospital
Kathmandu, Nepal, 44600
Sponsors and Collaborators
Uppsala University
UNICEF
Ministry of Health and Population, Nepal
The Swedish Society of Medicine
Investigators
Principal Investigator: Ola Andersson, MD PhD Uppsala University
Principal Investigator: Ashish KC, MD Uppsala University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02222805     History of Changes
Other Study ID Numbers: CCANEMIA11
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Uppsala University:
Cord clamping
Iron deficiency
Anemia
Iron
Hyperbilirubinemia
Jaundice
Neurodevelopment

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Jaundice
Jaundice, Neonatal
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases