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

Primary Purpose

Low Birth Weight, Perinatology, Iron Status

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Cord clamping
Sponsored by
Stanger Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Birth Weight

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanger Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Early cord clamping

Delayed cord clamping

Arm Description

Within 30 seconds after birth.

Between 2 and 3 minutes after birth

Outcomes

Primary Outcome Measures

Haemoglobin level

Secondary Outcome Measures

Hyperviscosity syndrome
Iron status
hyperbilirubinaemia

Full Information

First Posted
December 5, 2011
Last Updated
December 15, 2012
Sponsor
Stanger Hospital
Collaborators
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
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1. Study Identification

Unique Protocol Identification Number
NCT01487980
Brief Title
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants
Official Title
The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanger Hospital
Collaborators
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight, Perinatology, Iron Status, Cord Clamping

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early cord clamping
Arm Type
Active Comparator
Arm Description
Within 30 seconds after birth.
Arm Title
Delayed cord clamping
Arm Type
Experimental
Arm Description
Between 2 and 3 minutes after birth
Intervention Type
Procedure
Intervention Name(s)
Cord clamping
Intervention Description
Early vs Delayed
Primary Outcome Measure Information:
Title
Haemoglobin level
Time Frame
two months
Secondary Outcome Measure Information:
Title
Hyperviscosity syndrome
Time Frame
1 day
Title
Iron status
Time Frame
two months
Title
hyperbilirubinaemia
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: twin pregnancy history of postpartum haemorrhage (PPH) (gestational) diabetes pre-eclampsia abruptio placentae caesarian section necessity of early clamping due to tight nuchal cord need for resuscitation immediately after birth major congenital abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sybrich Tiemersma, MD
Organizational Affiliation
Stanger Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanger Hospital
City
Stanger
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa

12. IPD Sharing Statement

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

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