Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
Phase: NA
Conditions: Delayed Cord Clamping
Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
  
 
 
Title Form 
 
 
“Delayed umbilical cord clamping in elective Caesarean Section:  
What are the benefits?” 
 
 
 
Date: 15-10-2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
 
 
 
Study Protocol 
 
Principal Investigator 
Dr. Giuseppe De Bernardo, responsible S. S. Neonatal Intensive Care Unit 
Department of mother and child’s Health 
Poliambulanza Foundation, Brescia 
Co - principal investigator 
Dr.ssa Laura Linetti 
Neonatology Coordinator 
Poliambulanza Foundation, Brescia 
Statistic 
Maurizio Giordano 
University of Naples Federico II, School of Medicine 
 
INDEX 
 
1. Introduction 
2. Objective 
3. Study Location 
4. Population 
5. Inclusion Criteria 
6. Exclusion Criteria 
7. Procedure and Measurement 
8. Primary Outcome 
9. Secondary Outcome 
10. Sample Size 
11. Randomization 
12. Reference 
 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
  
 
 
 
 
1. Introduction 
 
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 (1).  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 (2-3). 
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 (4-5-6-7). 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 (8-9). 
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 (10). 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. 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
 
 
 
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 (11 ). Nowadays, researchers 
found no side effects of delayed umbilical cord clamping except a slight increase of 
phototherapy needs (12).  
 
 
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.  
 
2. Objective 
Objective of the study was evaluating the effect of delayed clamping on FC, SpO2, T, HGT, 
Ht and bilirubin in term newborns subjected to elective Caesarean Section 
 
3. Study Location 
- U.O.C. NICU-Neonatology – Department of mother and child’s Health 
Poliambulanza Foundation, Brescia 
- U.O. Gynecology ed Obstetrics - Villa Cinzia Clinic, struttura accreditata, Napoli 
 
4. Population 
46 term newborns (37-42 wks) subjected to Caesarean Section will be enrolled:  
1. Group (A): 23 newborns subjected to umbilical cord immediate clamping  
2. Group (B): 23 newborns subjected to umbilical cord delayed clamping 
 
5. Inclusion Criteria 
5.1 Mothers: 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
  
 
∙ Caesarean Section; 
∙ BMI = 19-24,9; 
∙ Age ≤ 37 years 
5.2 Newborns 
∙ Gestational Age: 37 e 42 wks 
∙ Birth Body Weight = Appropriate gestational age 
 
6. Exclusion Criteria 
6.1 Mothers 
∙ Pathologies; 
∙ Smoking mothers; 
∙ Assumption of drugs during pregnancy 
∙ Mother toxicomaniac 
6.2 Newborn 
∙ 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 
● Monochorionic twins 
∙ Fetal Hydrops 
∙ Umbilical cord damaged 
∙ Isoimmunization Rh 
∙ Respiratory and malformative diseases; 
∙ Small for gestational age 
∙ Large for gestational age 
∙ Temperature <36,5 C 
∙ Temperature > 37,5 C 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
 
 
 
∙ Acidosis 
 
7. Procedure and Measurement 
∙ Immediate umbilical cord clamping in the Group A 
∙ Delayed umbilical cord clamping after 1 min from birth in Group B 
In both groups will be evaluated: 
o Saturation:  
Saturation will be detected at 5 min and 10 min from birth by oximeter Covidien, positioning 
the probe on right hand/wrist of the newborn. References value are: 80-85% at 5 min and 85-
90% at 10 min (14); 
o Heart Rate: 
Heart rate will be detected at 5 min and 10 min from birth by cardiomonitor. Reference value 
are 100-150 bpm (15) 
o Temperature: Temperature will be revealed at 5 min and 10 min from birth by Panda 
Warmer (GE), the probe of the infant radiant warmer. Reference value are 36,5-37,5 C 
o Glycaemia: HGT will be detected at 120 min from birth by capillary blood sampling of 
the heel. The sample will be analysed by “ABL90 Flex” 
o Haematocrit: Ht will be revealed at 120 min and 72 hrs from birth by capillary blood 
sampling of the heel. The sample will be analysed by “ABL90 Flex” 
o Bilirubin: Bilirubin will be detected after 72 hrs from birth by capillary blood sampling of 
the heel. The sample will be analysed by “ABL90 Flex” 
 
8. Primary Outcome 
H0: The case group will show the same values respect to control group for HR, SpO2 and 
Temperature  
H1: The case group will show different values respect to control group for HR, SpO2 e 
Temperature 
 
 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
  
 
9. Secondary Outcome 
H0: The case group will show the same values respect to control group for HGT, bilirubin 
and Ht 
H1: The case group will show different values respect to control group for HGT, bilirubin 
and Ht  
 
10. Sample Size 
Primary outcome will be analysed by ANOVA, repeated measures, between-within. Setting: 
∙ alfa error: 5% 
∙ beta error: 10% 
∙ Number of groups: 2 
∙ Number of measurements: 2 
∙ Correlation of repeated measures: 0,5 
∙ Nonsphericity correlation: 1 
∙ Effect size: 0,25  
They will be enrolled 46 newborns (23 group A + 23 group B) 
Secondary outcome will be analysed by ANOVA test. Statistical analysis will be performed 
by IBM SPSS Statistics for Windows, version 25.0 (Armonk, NY: IBM Corp.) 
 
11. Randomization 
Non-commercial study, case-control, randomized, open. Patients will be assigned to Group A 
or Group B by statistical software. 
 
12. Reference 
 
1. Katheria A, Hosono S, El-Naggar W. A new wrinkle: Umbilical cord management (how, 
when, 
who). 
Semin 
Fetal 
Neonatal 
Med. 
2018 
Oct;23(5):321-326. 
doi: 
10.1016/j.siny.2018.07.003. Epub 2018 Jul 20. Review. 
2. Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW et al. (2013) Delaying cord 
clamping until ventilation onset improves cardiovascular function at birth in 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
 
 
 
preterm lambs. J Physiol; 591: 2113-26. 16. 
3. Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, 
McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping 
(physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm 
lambs. PLoS One. 2015 Feb 17;10(2): e0117504.  
4. Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on 
Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 
15;6(8):1399-1404. 
5. Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. 
Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- 
and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. Review. 
6. Backes CH, Rivera BK, Haque U, Bridge JA, Smith CV, Hutchon DJ, Mercer JS. Placental 
transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet 
Gynecol. 2014 Jul;124(1):47-56. 
7. Nevill E, Meyer MP. Effect of delayed cord clamping (DCC) on breathing and transition at 
birth in very preterm infants. Early Hum Dev. 2015 Jul;91(7):407-11.  
8.  Wafaa Taha Ibrahim Elgzar, Heba Abdel-Fatah Ibrahim, Hanan Heiba Elkhateeb.“Effects 
of Deferred Versus Early Umbilical Cord Clamping on Maternal and Neonatal Outcomes” - 
American Journal of Nursing Research, 2017,5(4), 115-128. 
9. Valero J, Desantes D, Perales-Puchalt A, Rubio J, Diago Almela VJ, Perales A. Effect of 
delayed umbilical cord clamping on blood gas analysis. Eur J Obstet Gynecol Reprod Biol. 
2012 May;162(1):21-3. 
10. Kc A, Rana N, Målqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of 
Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 
Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270.  
11. Zhou YB, Li HT, Zhu LP, Liu JM. Impact of cesarean section on placental transfusion 
and iron-related hematological indices in term neonates: a systematic review and meta-
analysis. Placenta. 2014 Jan;35(1):1-8.  

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
  
 
12. McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord 
clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 
2013 Jul 11;(7):CD004074 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOLLO di STUDIO PILOTA - TIMING 
Versione 1.0 del 09/08/2018 
 
 
 
 
SIGNATURE OF APPROVALS 
 
 
 
 
_______________________                                _______________________ 
       SIGNATURE                                                                               DATE 
 
 
_______________________                                _______________________ 
       SIGNATURE                                                                               DATE 
 
 
_______________________                                _______________________ 
       SIGNATURE                                                                               DATE 
 
15-10-2018
15-10-2018
15-10-2018