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| ID | Type | Description | Link |
|---|---|---|---|
| PR(AMI)18/2014 | Other Identifier | Hospital Universitari Vall d'Hebron Research Institute |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delayed umbilical cord occlusion | Procedure |
| ||
| early umbilical cord occlusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of red blood cell transfusions to the newborn | for the duration of hospital stay, an expected average of 2 months. | |
| Intraventricular Haemorrhage incidence | from delivery, for the duration of hospital stay, an expected average of 2 months. | |
| Maternal postpartum haemorrhage incidence | within 24 hours after birth | |
| Volume of neonatal red blood cell transfusions | for the duration of hospital stay, an expected average of 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality |
| up to 27 days after birth. |
| Measure | Description | Time Frame |
|---|---|---|
| APGAR score | 10 minutes after delivery | |
| Umbilical cord blood pH | 0-15 minutes after delivery | |
| Neonatal intubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melchor Carbonell, MD | Contact | 0034626470597 | xormd11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Melchor Carbonell Socias, MD | Hospital Vall d'Hebron | Principal Investigator |
| Angela Gregoraci, MD | Hospital Vall d'Hebron | Principal Investigator |
| Maria Goya Canino, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de la Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Procedure |
|
| Oxytocin | Drug |
|
| 0-30 minutes after delivery |
| Incidence of intensive reanimation of the newborn | Use of vasoactive drugs. | 0-30 minutes after delivery |
| Incidence of adverse events during hospital stay of the newborn. | for the duration of hospital stay, an expected average of 2 month. |
| Hospital Vall d'Hebron |
| Study Director |
| Maria Angeles Linde, MD | Hospital Vall d'Hebron | Study Director |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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