search
Back to results

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

Primary Purpose

Hematocrit Anemia, Acidosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Umbilical cord clamping at birth.
Sponsored by
Policlinico Abano Terme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hematocrit Anemia focused on measuring Placental transfusion, Natural, two-step delivery, Early cord clamping, Delayed cord clamping

Eligibility Criteria

1 Minute - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Vaginal delivery

Exclusion Criteria:

Cesarean delivery

Sites / Locations

  • Policlinico Abano Terme
  • Policlinico Abano Terme
  • Padua University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early cord clamping

Delayed cord clamping

Arm Description

Cord clamping at 60 seconds after birth.

Cord clamping at 180 seconds after birth.

Outcomes

Primary Outcome Measures

Placental transfusion.
Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
Cord blood pH
pH estimate in arterial cord blood gas analysis

Secondary Outcome Measures

Full Information

First Posted
July 1, 2020
Last Updated
September 15, 2021
Sponsor
Policlinico Abano Terme
search

1. Study Identification

Unique Protocol Identification Number
NCT04459442
Brief Title
Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping
Official Title
Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Abano Terme

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematocrit Anemia, Acidosis
Keywords
Placental transfusion, Natural, two-step delivery, Early cord clamping, Delayed cord clamping

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early cord clamping
Arm Type
Experimental
Arm Description
Cord clamping at 60 seconds after birth.
Arm Title
Delayed cord clamping
Arm Type
Experimental
Arm Description
Cord clamping at 180 seconds after birth.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord clamping at birth.
Other Intervention Name(s)
Cord clamping
Intervention Description
Umbilical cord clamping after delivery.
Primary Outcome Measure Information:
Title
Placental transfusion.
Description
Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
Time Frame
Second day of life
Title
Cord blood pH
Description
pH estimate in arterial cord blood gas analysis
Time Frame
Second day of life.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vaginal delivery Exclusion Criteria: Cesarean delivery
Facility Information:
Facility Name
Policlinico Abano Terme
City
Abano Terme
State/Province
Padua
ZIP/Postal Code
35031
Country
Italy
Facility Name
Policlinico Abano Terme
City
Abano Terme
Country
Italy
Facility Name
Padua University Hospital
City
Padua
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No. There is not a plan to make IPD available

Learn more about this trial

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

We'll reach out to this number within 24 hrs