NCT01620008

Brief Summary

The purpose of this study is to determine if delaying cord clamping at the birth of term infants effects the early brain development (myelin deposition)as determined by quantitative MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will help to establish a scientific basis for the timing of cord clamping with reference to brain development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

6.3 years

First QC Date

June 12, 2012

Last Update Submit

September 29, 2021

Conditions

Iron Deficiency

Keywords

cord clamping (delayed or immediate)Myelin contentFerritin

Outcome Measures

Primary Outcomes (1)

  • Brain Myelin Volume

    At 4 months of age, term infants exposed to delayed cord clamping will have greater myelin content when compared to infants exposed to immediate cord clamping

    4 months of age

Secondary Outcomes (1)

  • Ferritin levels

    4 months of age

Study Arms (2)

Immediate Cord Clamping (ICC)

NO INTERVENTION

The infant will be placed on the maternal abdomen and the umbilical cord will be clamped immediately after birth (routine care).

Delayed Cord Clamping (DCC)

EXPERIMENTAL

At birth, infants will be placed on the maternal abdomen and the cord clamping will be delayed for 5 minutes. If the provider is unable to delay the cord clamping, the cord will be milked 5 times.

Procedure: Delayed Cord Clamping

Interventions

Delayed Cord ClampingPROCEDURE

At birth, the infant will be placed on the maternal abdomen and the umbilical will either be cut immediately or after a 5 minute delay.

Also known as: delayed umbilical cord clamping
Delayed Cord Clamping (DCC)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women in the third trimester with:
  • singleton pregnancy
  • planning to breastfeed for six months
  • English speaking
  • planning vaginal birth

You may not qualify if:

  • major medical or obstetrical complications
  • Intrauterine growth restriction
  • chorioamnionitis
  • familial learning disability
  • major psychiatric or depressive illness
  • fetal congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (4)

  • Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.

    PMID: 22843002BACKGROUND

  • Mercer JS, Erickson-Owens DA. Is it time to rethink cord management when resuscitation is needed? J Midwifery Womens Health. 2014 Nov-Dec;59(6):635-644. doi: 10.1111/jmwh.12206. Epub 2014 Oct 8.

    PMID: 25297530BACKGROUND

  • Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.

    PMID: 33912524DERIVED

  • Mercer JS, Erickson-Owens DA, Deoni SCL, Dean DC 3rd, Collins J, Parker AB, Wang M, Joelson S, Mercer EN, Padbury JF. Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial. J Pediatr. 2018 Dec;203:266-272.e2. doi: 10.1016/j.jpeds.2018.06.006. Epub 2018 Jul 6.

    PMID: 30473033DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Judith S Mercer, PhD, CNM

    Women & Infants Hospital of Rhode Island, University of Rhode Island

    PRINCIPAL INVESTIGATOR

  • Debra A Erickson-Owens, PhD, CNM

    University of Rhode Island; Women & Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

  • Sean C. Deoni, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized trial (with a preference arm)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

October 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

US(1)