CORD CLAMPING STUDY: Early versus delayed cord clamping and its effects on infant heart rate and oxygen saturation in the first minutes after birth.

In newly born infants, greater or equal to 32 weeks gestation, does early cord clamping < 60s after birth versus delaying cord clamping (90 to 180s) after birth, or after breathing has established, result in less bradycardia (Heart rate (HR) <100 bpm), when HR is measured 90s after birth?

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000253606

Acronym

TOCC - Time of Cord Clamping Study

Enrollment

Registered

2014-03-10

Start date

2014-07-01

Completion date

2015-07-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The active management of the third stage of labour involves clamping and cutting the umbilical cord and application of controlled cord traction after adminstration of syntometrine, to deliver the placenta. The optimal timing of cord clamping is unknown and practice varies amongst professionals globally. Many healthy newly born infants experience bradycardia (heart rate less than 100 beats per minute) in the first few minutes. The timing of clamping the umbilical cord may influence the proportion of babies experiencing bradycardia. The aims of this randomised controlled study are 1. To determine if delaying clamping of the cord reduces bradycardia in the first minutes after birth in near term and term infants 2. To determine if delaying clamping of the cord has an effect on the need for delivery room resuscitation 3. To determine if there is a difference in heart rate and oxygen saturation centiles in the first 10 mins after birth in three groups of infants (i) born after early (< 60s after birth) cord clamping compared to (ii) infants born after delayed (90-180 s after birth) cord clamping or (iii) when the umbilical cord is clamped following the onset of regular respirations (10 s after accoucher determines onset of regular respirations) by the infant.

Interventions

There are three intervention groups 1. Early cord clamping group ( <60s after birth) 2. Delayed cord clamping (> 90s but less than 180s after birth) 2. Clamping the cord 10s after crying and breathing has been established

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

32 Weeks to 42 Weeks

Healthy volunteers

Inclusion criteria

Any infant over or equal to 32 weeks’ gestation born at RWH is eligible for inclusion in the cord clamping study unless they meet exclusion criteria

Exclusion criteria

*Multiple birth *Fetal bradycardia /fetal distress where birth is expedited with C/S or instrumental delivery *Nuchal cord requiring division before birth of the infant *Maternal general anaesthetic *Placenta praevia *Vasa praevia *Planned lotus birth *Planned water birth *Known congenital anomalies necessitating early transfer to a surgical centre *Infants >= 37 weeks gestation enrolled in the Flamingo study (possible effect of cord clamping on cord gas measurements in Flamingo study) *Non-English speaking parents unable to provide informed consent *Infants whose parents have elected to have their infant’s cord blood banked *Parents with a birth plan detailing management of the third stage including timing of cord clamping and cutting

Outcome results