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Clinical Trials/NCT04459442
NCT04459442UnknownNot Applicable

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

Policlinico Abano Terme4 sites in 1 country90 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
90
Locations
4
Primary Endpoint
Placental transfusion.

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Investigator)

Masking Description

None (Open Label)

Eligibility Criteria

Ages
1 Minute to 2 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Vaginal delivery

Exclusion Criteria

  • Cesarean delivery

Outcomes

Primary Outcomes

Placental transfusion.

Time Frame: Second day of life

Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.

Cord blood pH

Time Frame: Second day of life.

pH estimate in arterial cord blood gas analysis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Policlinico Abano Terme
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vincenzo Zanardo

Professor

Policlinico Abano Terme

Study Sites (4)

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