Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

December 15, 2012 updated by: S. Tiemersma, Stanger Hospital

The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Stanger, KwaZulu-Natal, South Africa, 4450
        • Stanger Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion Criteria:

  1. twin pregnancy
  2. history of postpartum haemorrhage (PPH)
  3. (gestational) diabetes
  4. pre-eclampsia
  5. abruptio placentae
  6. caesarian section
  7. necessity of early clamping due to tight nuchal cord
  8. need for resuscitation immediately after birth
  9. major congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Early cord clamping
Within 30 seconds after birth.
Procedure: Cord clamping
Early vs Delayed
EXPERIMENTAL: Delayed cord clamping
Between 2 and 3 minutes after birth
Procedure: Cord clamping
Early vs Delayed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Haemoglobin level
Time Frame: two months
two months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hyperviscosity syndrome
Time Frame: 1 day
1 day
Iron status
Time Frame: two months
two months
hyperbilirubinaemia
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanger Hospital

Collaborators

Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)

Investigators

  • Principal Investigator: Sybrich Tiemersma, MD, Stanger Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (ESTIMATE)

December 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 15, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-LBW-SA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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