Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

April 15, 2020 updated by: Vincenzo Zanardo, Policlinico Abano Terme

Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine 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 and placental transfusion. The most effective way to manage umbilical cord in in '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 (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by '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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 2 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Vaginal delivery Gestational age >37 weeks Natural process of labor

Exclusion Criteria:

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early cord clamping
Cord clamping at 60 seconds after birth.
Umbilical cord clamping after delivery.
EXPERIMENTAL: Delayed cord clamping
Cord clamping at 180 seconds after birth,
Umbilical cord clamping after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental transfusion
Time Frame: Second day of life
We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.
Second day of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial cord blood gas analysis.
Time Frame: Second day of life.
Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Second day of life.
Neonatal body weight decrease.
Time Frame: First and second day of life
Neonatal body weight (Kg) and weight at discharge (Kg)
First and second day of life
Blood gases
Time Frame: At birth
pH (units)
At birth
Lactate
Time Frame: At birth
mmol/L
At birth
Glucose
Time Frame: At birth
mg%
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (ACTUAL)

April 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Placental Transfusion

Clinical Trials on Cord clamping

3
Subscribe