Delayed Cord Clamping in Infants Born by Cesarean Section

Elective Cesarean Section Clinical Trial

Official title:

Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549884
• Other study ID #: 4443/AO/18
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: April 2020
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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)

Related Conditions & MeSH terms

• Elective Cesarean Section
• Umbilical Cord Management

Intervention

Procedure:
• Delayed cord clamping
Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section
• Early cord clamping
Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Wyllie J, Bruinenberg J, Roehr CC, Rüdiger 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit		Day 2 of life
Secondary	Preductal transcutaneous saturation (TcSaO2)		During the first 10 minutes of life
Secondary	Heart rate	(bpm)	During the first 10 minutes of life
Secondary	Arterial blood pressure	(mmHg)	At day 1, 2, 3 of life
Secondary	Total transcutaneous bilirubin	(mg/dl)	Day 3 of life
Secondary	Maternal blood losses	ml	At delivery
Secondary	Temperature at Normal nursery admission	Celsius degrees	At the time of normal nursery admission
Secondary	Time to the first breath	seconds	At birth
Secondary	Weight	g	Day 3 of life