Clinical trial NCT03549884: Delayed Cord Clamping in Infants Born by Cesarean Section
Official title: Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Cord Management
Elective Cesarean Section
Keywords: Early cord Clamping
Delayed cord clamping
Full term infant
Elective cesarean section
Hematocrit
Postnatal adaptation
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section remains to be established.

Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.


Eligibility criteria: Inclusion Criteria:

* Elective cesarean section
* Gestational age \> or = 39 weeks
* No labor
* Single pregnancy
* Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian

Exclusion Criteria:

* Emergent or urgent cesarean sections
* Twin pregnancies
* Parental refusal to participate to the study
* Major congenital malformations (such as cardiopathies)
* Chromosomic abnormalities
* Fetal hydrops
* Severe maternal diseases (such as hypertension)
* Cord abnormalities (length \< 20 cm, funicular prolapse, funicular knots)
* Intrauterine growth restriction (IUGR)

Primary outcomes:
measure: Hematocrit
timeFrame: Day 2 of life
Secondary outcomes:
measure: Preductal transcutaneous saturation (TcSaO2)
timeFrame: During the first 10 minutes of life
measure: Heart rate
timeFrame: During the first 10 minutes of life
measure: Arterial blood pressure
timeFrame: At day 1, 2, 3 of life
measure: Total transcutaneous bilirubin
timeFrame: Day 3 of life
measure: Maternal blood losses
timeFrame: At delivery
measure: Temperature at Normal nursery admission
timeFrame: At the time of normal nursery admission
measure: Time to the first breath
timeFrame: At birth
measure: Weight
timeFrame: Day 3 of life
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, University of Padova
Study officials:
affiliation: University of Padova, Italy
name: Daniele Trevisanuto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
citation: Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.
citation: Katheria AC, Brown MK, Rich W, Arnell K. Providing a Placental Transfusion in Newborns Who Need Resuscitation. Front Pediatr. 2017 Jan 25;5:1. doi: 10.3389/fped.2017.00001. eCollection 2017.
citation: 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. doi: 10.1016/j.placenta.2013.10.011. Epub 2013 Nov 20.
citation: Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
citation: Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.