Delayed Umbilical Cord Clamping Benefits, Intraventricular Haemorrhage, Postpartum Haemorrhage
Conditions
Brief 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. 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.
Interventions
PROCEDUREdelayed umbilical cord occlusion
PROCEDUREearly umbilical cord occlusion
DRUGOxytocin
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Fetal hydrops * Severe Iso- Immunization * HIV-positive mother * Severe Intrauterine growth restriction ( Reverse atrial Flow in DV) * Intrauterus Ventricular haemorrhage
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal mortality | up to 27 days after birth. | * early ( 0 to 6 days after birth) * late ( 7 to 27 days after birth) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Umbilical cord blood pH | 0-15 minutes after delivery | — |
| Neonatal intubation | 0-30 minutes after delivery | — |
| Incidence of intensive reanimation of the newborn | 0-30 minutes after delivery | Use of vasoactive drugs. |
| Incidence of adverse events during hospital stay of the newborn. | for the duration of hospital stay, an expected average of 2 month. | — |
| APGAR score | 10 minutes after delivery | — |
Countries
Spain
Contacts
Primary ContactMelchor Carbonell, MD
Outcome results
None listed