- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487980
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
-
-
KwaZulu-Natal
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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:
- 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
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.
|
Early vs Delayed
|
EXPERIMENTAL: Delayed cord clamping
Between 2 and 3 minutes after birth
|
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
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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