NCT01487980

Brief Summary

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

December 5, 2011

Last Update Submit

December 15, 2012

Conditions

Low Birth WeightPerinatologyIron StatusCord Clamping

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin level

    two months

Secondary Outcomes (3)

  • Hyperviscosity syndrome

    1 day

  • Iron status

    two months

  • hyperbilirubinaemia

    2 days

Study Arms (2)

Early cord clamping

ACTIVE COMPARATOR

Within 30 seconds after birth.

Procedure: Cord clamping

Delayed cord clamping

EXPERIMENTAL

Between 2 and 3 minutes after birth

Procedure: Cord clamping

Interventions

Cord clampingPROCEDURE

Early vs Delayed

Delayed cord clampingEarly cord clamping

Eligibility Criteria

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

You may not qualify if:

  • twin pregnancy
  • history of postpartum haemorrhage (PPH)
  • (gestational) diabetes
  • pre-eclampsia
  • abruptio placentae
  • caesarian section
  • necessity of early clamping due to tight nuchal cord
  • need for resuscitation immediately after birth
  • major congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanger Hospital

KwaDukuza, KwaZulu-Natal, 4450, South Africa

Location

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sybrich Tiemersma, MD

    Stanger Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Officer

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

ZA(1)