Delayed Umbilical Cord Clamping BenefitsCODE-PNCT02187874
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
A study testing delayed umbilical cord occlusion, early umbilical cord occlusion and Oxytocin in people with Delayed Umbilical Cord Clamping Benefits and Postpartum Haemorrhage, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage
- What is being tested?
- delayed umbilical cord occlusion, early umbilical cord occlusion and Oxytocin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Jul 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.
- Patients must be over 18 years old.
- Patient understands and signs informed consent.
Who cannot join
- Urgent C-section
- gestational age under 22 or over 33 weeks
- Major fetal anomalies (requiring surgery or with a high risk of neonatal death or incapacity)
- Major uterine malformations
- Placenta previa.
- Multiple gestations
Show all 11Show fewer
- Fetal hydrops
- Severe Iso- Immunization
- HIV-positive mother
- Severe Intrauterine growth restriction ( Reverse atrial Flow in DV)
- Intrauterus Ventricular haemorrhage
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de la Vall d'Hebron
Barcelona, Barcelona, 08035
Melchor Carbonell, MD, 0034626470597, xormd11@gmail.com
About this study
Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.
However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.
Read more
Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.
Secondary outcomes:
- To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.
- Neonatal mortality and morbidity
- Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage
- To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.
- Conditions
- Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage
- Being tested
- delayed umbilical cord occlusion, early umbilical cord occlusion, Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed umbilical cord occlusionProcedure or surgery
early umbilical cord occlusionProcedure or surgery
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| early umbilical cord occlusion | Active comparator | Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly. Receives: Procedure: early umbilical cord occlusion; Drug: Oxytocin |
| delayed umbilical cord occlusion | Experimental | One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.
60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly. Receives: Procedure: delayed umbilical cord occlusion; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of red blood cell transfusions to the newborn
Measured: for the duration of hospital stay, an expected average of 2 months.
Intraventricular Haemorrhage incidence
Measured: from delivery, for the duration of hospital stay, an expected average of 2 months.
Maternal postpartum haemorrhage incidence
Measured: within 24 hours after birth
Volume of neonatal red blood cell transfusions
Measured: for the duration of hospital stay, an expected average of 2 months.
Secondary outcomes (1)
Neonatal mortality
- early ( 0 to 6 days after birth)
- late ( 7 to 27 days after birth)
Measured: up to 27 days after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Umbilical Cord Clamping BenefitsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melchor Carbonell Socias, MD, Principal investigator, Hospital Vall d'HebronAngela Gregoraci, MD, Principal investigator, Hospital Vall d'HebronMaria Goya Canino, MD, Study director, Hospital Vall d'HebronMaria Angeles Linde, MD, Study director, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187874
- Sponsor's protocol ID
- PR(AMI)18/2014
- Other IDs
- PR(AMI)18/2014
- Acronym
- CODE-P
- Status last verified
- Apr 2016
- First submitted
- 9 Jul 2014
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
- ClinicalTrials.gov ID
- NCT02187874
- Acronym / sponsor ID
- CODE-P / PR(AMI)18/2014
- Conditions
- Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 11 Jul 2014 (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.
Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.
However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.
Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.
Secondary outcomes:
- To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.
- Neonatal mortality and morbidity
- Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage
- To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early umbilical cord occlusion | Active comparator | Procedure: early umbilical cord occlusion, Drug: OxytocinCord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly. |
| delayed umbilical cord occlusion | Experimental | Procedure: delayed umbilical cord occlusion, Drug: OxytocinOne of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures. 60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.
- Patients must be over 18 years old.
- Patient understands and signs informed consent.
Key exclusion criteria (11 listed)
- Urgent C-section
- gestational age under 22 or over 33 weeks
- Major fetal anomalies (requiring surgery or with a high risk of neonatal death or incapacity)
- Major uterine malformations
- Placenta previa.
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 |
|---|---|---|
| delayed umbilical cord occlusion | Procedure or surgery | delayed umbilical cord occlusion |
| early umbilical cord occlusion | Procedure or surgery | early umbilical cord occlusion |
| Oxytocin | Drug | delayed umbilical cord occlusion, early umbilical cord occlusion |
Primary outcome
Number of red blood cell transfusions to the newborn
Time frame: for the duration of hospital stay, an expected average of 2 months.
Intraventricular Haemorrhage incidence
Time frame: from delivery, for the duration of hospital stay, an expected average of 2 months.
Maternal postpartum haemorrhage incidence
Time frame: within 24 hours after birth
Volume of neonatal red blood cell transfusions
Time frame: for the duration of hospital stay, an expected average of 2 months.
1 secondary outcome
Neonatal mortality
Time frame: up to 27 days after birth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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.
Melchor Carbonell Socias, MD principal investigator
Hospital Vall d'Hebron
Angela Gregoraci, MD principal investigator
Hospital Vall d'Hebron
Maria Goya Canino, MD study director
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed umbilical cord occlusion, early umbilical cord occlusion and Oxytocin in people with Delayed Umbilical Cord Clamping Benefits and Postpartum Haemorrhage, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Apr 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melchor Carbonell, MD (0034626470597, xormd11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of red blood cell transfusions to the newborn (time frame: for the duration of hospital stay, an expected average of 2 months.). The study lists 4 primary outcomes in all. 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 26 Apr 2016.