Umbilical Cord Clamping: What Are the Benefits

Study Overview
=================
Brief Summary
-----------------
Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.

Detailed Description
-----------------
Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output. A lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age. In a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood. Association of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping: Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh. Researchers concluded that newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Haematocrit difference was greater between newborns birth by elective Caesarean Section compared to those birth by Caesarean Section in labor. Nowadays, researchers found no side effects of delayed umbilical cord clamping except a slight increase of phototherapy needs. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section. The aim of the study protocol is to investigate the effects of the clamping after 1 min from birth by elective Caesarean Section on heart rate, saturation, body temperature, bilirubin, haematocrit and glycemia.

Official Title
-----------------
Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits

Conditions
-----------------
Delayed Cord Clamping

Intervention / Treatment
-----------------
* Procedure: Delayed umbilical cord clamping
* Procedure: Immediate umbilical cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth Body Weight = appropriate for gestational age Delivery mode= Elective Caesarean Section Mothers' BMI = 19-24,9 Mothers'age ≤ 37 years Exclusion Criteria: Admission in NICU; Neonatal Resuscitation Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest Pathologies ; Smoking mothers; Assumption of drugs during pregnancy Mother toxicomaniac

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Newborns will be subjected to umbilical cord immediate clamping | Procedure: Immediate umbilical cord clamping<br>* Umbilical cord will be clamped immediately after the birth of the newborn<br>|
| Experimental: Study Group<br>Newborns will be subjected to umbilical cord delayed clamping | Procedure: Delayed umbilical cord clamping<br>* Umbilical cord will be clamped after 1 min after the birth of the newborn<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Heart Rate After Delayed Umbilical Clamping | It will be measured the change of heart rate (HR) | 5 minutes and 10 minutes after birth | 
| Change of Saturation After Delayed Umbilical Clamping | Saturation change (SpO2) | 5 minutes and 10 minutes after birth | 
| Change of Temperature After Delayed Umbilical Clamping | Temperature change (T) | 5 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping | hemo gluco test (HGT) | 120 minutes after birth | 
| Misuration of the Hematocrit After Delayed Umbilical Clamping | hematocrit (Ht) | 72 hours of life | 
| Misuration of the Bilirubin After Delayed Umbilical Clamping | bilirubin | 72 hours of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborn, Elective Caesaren Section, Cord Clamping