Umbilical Cord Clamping: What Are the Benefits
- Conditions
- Delayed Cord Clamping
- Interventions
- Procedure: Delayed umbilical cord clampingProcedure: Immediate umbilical cord clamping
- Registration Number
- NCT03878602
- Lead Sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- Birth Body Weight = appropriate for gestational age
- Delivery mode= Elective Caesarean Section
- Mothers' BMI = 19-24,9
- Mothers'age ≤ 37 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group Delayed umbilical cord clamping Newborns will be subjected to umbilical cord delayed clamping Control Group Immediate umbilical cord clamping Newborns will be subjected to umbilical cord immediate clamping
- Primary Outcome Measures
Name Time Method Change of Temperature After Delayed Umbilical Clamping 5 minutes after birth Temperature change (T)
Change of Saturation After Delayed Umbilical Clamping 5 minutes and 10 minutes after birth Saturation change (SpO2)
Change of Heart Rate After Delayed Umbilical Clamping 5 minutes and 10 minutes after birth It will be measured the change of heart rate (HR)
- Secondary Outcome Measures
Name Time Method Misuration of the Hematocrit After Delayed Umbilical Clamping 72 hours of life hematocrit (Ht)
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping 120 minutes after birth hemo gluco test (HGT)
Misuration of the Bilirubin After Delayed Umbilical Clamping 72 hours of life bilirubin
Trial Locations
- Locations (1)
Department of mother and child's Health Poliambulanza Foundation
🇮🇹Brescia, Italy