Trials / Unknown
UnknownNCT02187874
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | delayed umbilical cord occlusion | |
| PROCEDURE | early umbilical cord occlusion | |
| DRUG | Oxytocin |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2017-07-01
- First posted
- 2014-07-11
- Last updated
- 2016-04-26
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02187874. Inclusion in this directory is not an endorsement.