Effect of timing of cord clamping on postnatal packed red blood cells value and clinical outcome in term newborns: a randomised controlled trial

ISRCTN	ISRCTN97552320
DOI	https://doi.org/10.1186/ISRCTN97552320
Protocol serial number	N/A
Sponsor	United Nations Children's Fund (UNICEF) (Argentina)
Funder	United Nations Children's Fund (UNICEF) (Argentina)

Submission date: 18/02/2005
Registration date: 02/03/2005
Last edited: 18/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Guillermo Carroli
Scientific

Pueyrredón 985
Rosario
2000
Argentina

Phone	+54 (0)341 447 2625
Email	gcarroli@crep.com.ar

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine the effect of timing of umbilical cord clamping on neonatal venous haematocrit, clinical outcome and maternal postpartum haemorrhage.
Ethics approval(s)	The trial was approved by the ethics committees of both hospitals (Hospital Italiano de Buenos Aires protocol number: 681/2002).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Venous haematocrit six hours after birth.
Key secondary outcome measure(s)	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
Completion date	28/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	276
Key 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)
Key exclusion criteria	Does not comply with above inclusion criteria
Date of first enrolment	27/11/2002
Date of final enrolment	28/04/2003

Locations

Countries of recruitment

Argentina

Study participating centre

Pueyrredón 985

Rosario
2000
Argentina

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/04/2006		Yes	No