Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping

The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental acidosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Acidosis; Hematocrit Anemia
• Intervention / Treatment: Procedure: Umbilical cord clamping at birth.

Detailed Description

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable transition from fetal to extrauterine life, with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during' natural', 'two-step delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values (placental transfusion). The most effective way to manage umbilical cord in in 'natural', two-step delivery remains to be established. Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management ECC vs. DCC) on the placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.

Material and methods: This is a randomized clinical trial on the effect of different cord management in newborns by 'natural', two-step delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio, according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Abano Terme, Italy
    • Policlinico Abano Terme
  • Padua, Italy, 35128
    • PADUA UNIVERSITY HOSPITAL
  • Padua
    • Abano Terme, Padua, Italy, 35031
      • Policlinico Abano Terme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Vaginal delivery

Exclusion Criteria:

Cesarean delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early cord clamping; Cord clamping at 60 seconds after birth.	Procedure: Umbilical cord clamping at birth.; Umbilical cord clamping after delivery.; Other Names: Cord clamping
Experimental: Delayed cord clamping; Cord clamping at 180 seconds after birth.	Procedure: Umbilical cord clamping at birth.; Umbilical cord clamping after delivery.; Other Names: Cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental transfusion.	Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.	Second day of life
Cord blood pH	pH estimate in arterial cord blood gas analysis	Second day of life.

Collaborators and Investigators

• Sponsor: Policlinico Abano Terme

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): October 15, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Delayed cord clamping; Placental transfusion; Early cord clamping; Natural, two-step delivery
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: 3278/AT/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No