Condition category
Pregnancy and Childbirth
Date applied
18/02/2005
Date assigned
02/03/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guillermo Carroli

ORCID ID

Contact details

Pueyrredón 985
Rosario
2000
Argentina
+54 (0)341 447 2625
gcarroli@crep.com.ar

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To determine the effect of timing of umbilical cord clamping on neonatal venous haematocrit, clinical outcome and maternal postpartum haemorrhage.

Ethics approval

The trial was approved by the ethics committees of both hospitals (Hospital Italiano de Buenos Aires protocol number: 681/2002).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Timing of cord clamping on newborns at term

Intervention

1. Early cord clamping within the first 15 seconds of life
2. Cord clamping at first minute of life
3. Cord clamping at third minute of life

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Venous haematocrit six hours after birth.

Secondary outcome measures

1. Neonatal haematocrit at 24 - 48 hours of age
2. Plasma bilirubin level at 24 - 48 hours of age
3. Early neonatal morbidity (tachypnea, respiratory grunting, respiratory distress, jaundice, seizures, sepsis, necrotising enterocolitis, neonatal death)
4. Admission to Neonatal Intensive Care Unit
5. Length of newborn hospital stay
6. Any neonatal disease that occurs between birth and one month of age
7. Weight and type of feeding at one month of age
8. Postpartum maternal blood loss volume
9. Maternal haematocrit level at 24 hours postpartum

Overall trial start date

27/11/2002

Overall trial end date

28/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Women were eligible if they had uneventful cephalic vaginal or cesarean section delivery with the following characteristics:
1. Singleton pregnancy at term
2. No evidence of clinical disease (diabetes, preeclampsia, hypertension) or any other complications
3. No evidence of congenital malformations or intrauterine growth restriction (estimated foetal weight less than 10th percentile)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

276

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

27/11/2002

Recruitment end date

28/04/2003

Locations

Countries of recruitment

Argentina

Trial participating centre

Pueyrredón 985
Rosario
2000
Argentina

Sponsor information

Organisation

United Nations Children's Fund (UNICEF) (Argentina)

Sponsor details

Junin 1940
Buenos Aires
C 1113AAX
Argentina
+54 (0)11 5093 7100
mthourte@unicef.org

Sponsor type

Research organisation

Website

http://www.unicef.org/argentina/

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF) (Argentina)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16567393

Publication citations

  1. Results

    Ceriani Cernadas JM, Carroli G, Pellegrini L, Otaño L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizábal J, The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial., Pediatrics, 2006, 117, 4, e779-86, doi: 10.1542/peds.2005-1156.

Additional files

Editorial Notes