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

NCT ID: NCT04459442

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-30

Brief Summary

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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

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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).

Conditions

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Hematocrit Anemia Acidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
None (Open Label)

Study Groups

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Early cord clamping

Cord clamping at 60 seconds after birth.

Group Type EXPERIMENTAL

Umbilical cord clamping at birth.

Intervention Type PROCEDURE

Umbilical cord clamping after delivery.

Delayed cord clamping

Cord clamping at 180 seconds after birth.

Group Type EXPERIMENTAL

Umbilical cord clamping at birth.

Intervention Type PROCEDURE

Umbilical cord clamping after delivery.

Interventions

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Umbilical cord clamping at birth.

Umbilical cord clamping after delivery.

Intervention Type PROCEDURE

Other Intervention Names

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Cord clamping

Eligibility Criteria

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Inclusion Criteria

Vaginal delivery

Exclusion Criteria

Cesarean delivery
Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Abano Terme

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Zanardo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Abano Terme

Abano Terme, Padua, Italy

Site Status

Policlinico Abano Terme

Abano Terme, , Italy

Site Status

Padua University Hospital

Padua, , Italy

Site Status

Countries

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Italy

Other Identifiers

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3278/AT/14

Identifier Type: -

Identifier Source: org_study_id

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