NCT04459442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

July 1, 2020

Last Update Submit

September 15, 2021

Conditions

Hematocrit AnemiaAcidosis

Keywords

Placental transfusionNatural, two-step deliveryEarly cord clampingDelayed cord clamping

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Early cord clamping

EXPERIMENTAL

Cord clamping at 60 seconds after birth.

Procedure: Umbilical cord clamping at birth.

Delayed cord clamping

EXPERIMENTAL

Cord clamping at 180 seconds after birth.

Procedure: Umbilical cord clamping at birth.

Interventions

Umbilical cord clamping at birth.PROCEDURE

Umbilical cord clamping after delivery.

Also known as: Cord clamping
Delayed cord clampingEarly cord clamping

Eligibility Criteria

Age1 Minute - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Vaginal delivery

You may not qualify if:

  • Cesarean delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Policlinico Abano Terme

Abano Terme, Padua, 35031, Italy

Location

Policlinico Abano Terme

Abano Terme, Italy

Location

Padua University Hospital

Padua, 35128, Italy

Location

MeSH Terms

Conditions

AcidosisFetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
None (Open Label)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

February 1, 2021

Primary Completion

October 15, 2021

Study Completion

December 30, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

No. There is not a plan to make IPD available

Locations

IT(3)