Low Birth WeightNCT01487980
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants
A study testing Cord clamping in people with Low Birth Weight and Perinatology, run by Stanger Hospital at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight, Perinatology, Iron Status
- What is being tested?
- Cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- twin pregnancy
- history of postpartum haemorrhage (PPH)
- (gestational) diabetes
- pre-eclampsia
- abruptio placentae
- caesarian section
Show all 9Show fewer
- necessity of early clamping due to tight nuchal cord
- need for resuscitation immediately after birth
- major congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Birth Weight, Perinatology, Iron Status, Cord Clamping
- Being tested
- Cord clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord clampingProcedure or surgery
Early vs Delayed
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping | Active comparator | Within 30 seconds after birth. Receives: Procedure: Cord clamping |
| Delayed cord clamping | Experimental | Between 2 and 3 minutes after birth Receives: Procedure: Cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level
Measured: two months
Secondary outcomes (3)
Hyperviscosity syndrome
Measured: 1 day
Iron status
Measured: two months
hyperbilirubinaemia
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanger Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
- Responsible party
- Principal investigator, S. Tiemersma, Stanger Hospital
- Investigators
- Sybrich Tiemersma, MD, Principal investigator, Stanger Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487980
- Sponsor's protocol ID
- DCC-LBW-SA
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.
- ClinicalTrials.gov ID
- NCT01487980
- Acronym / sponsor ID
- DCC-LBW-SA
- Conditions
- Low Birth Weight, Perinatology, Iron Status, Cord Clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Stanger HospitalUniversity, hospital or other
- Collaborators
- Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping | Active comparator | Procedure: Cord clampingWithin 30 seconds after birth. |
| Delayed cord clamping | Experimental | Procedure: Cord clampingBetween 2 and 3 minutes after birth |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- twin pregnancy
- history of postpartum haemorrhage (PPH)
- (gestational) diabetes
- pre-eclampsia
- abruptio placentae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord clampingEarly vs Delayed | Procedure or surgery | Delayed cord clamping, Early cord clamping |
Primary outcome
Haemoglobin level
Time frame: two months
3 secondary outcomes
Hyperviscosity syndrome
Time frame: 1 day
Iron status
Time frame: two months
hyperbilirubinaemia
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sybrich Tiemersma, MD principal investigator
Stanger Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cord clamping in people with Low Birth Weight and Perinatology, run by Stanger Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin level (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.