NCT04351997

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

March 28, 2020

Last Update Submit

April 15, 2020

Conditions

Placental TransfusionHematocrit Anemia

Keywords

Placental transfusionTwo-step deliveryEarly cord clampingDelayed cord clamping

Outcome Measures

Primary Outcomes (1)

  • Placental transfusion

    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 Outcomes (5)

  • Arterial cord blood gas analysis.

    Second day of life.

  • Neonatal body weight decrease.

    First and second day of life

  • Blood gases

    At birth

  • Lactate

    At birth

  • Glucose

    At birth

Study Arms (2)

Early cord clamping

EXPERIMENTAL

Cord clamping at 60 seconds after birth.

Procedure: Cord clamping

Delayed cord clamping

EXPERIMENTAL

Cord clamping at 180 seconds after birth,

Procedure: Cord clamping

Interventions

Cord clampingPROCEDURE

Umbilical cord clamping after delivery.

Delayed cord clampingEarly cord clamping

Eligibility Criteria

Age2 Days - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Vaginal delivery Gestational age \>37 weeks Natural process of labor

You may not qualify if:

  • Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

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

Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia, 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
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 17, 2020

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

No: There is not a plan to make IPD available.

Locations

IT(3)