Effect of timing of oxytocin administration during delayed cord clamping in term infants

The effect of timing of intramuscular oxytocin administration on neonatal arterial oxygen saturation during delayed cord clamping in vaginal births. at term

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001299594

Acronym

OACC

Enrollment

Registered

2015-11-30

Start date

2016-03-04

Completion date

2018-01-27

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

Delayed cord clamping (DCC) is slowly becoming common practice in the management of uncomplicated births in Australia, however it is unclear how the administration of maternal uterotonics such as oxytocin as part of the active management of the third stage of labour have on the newborn DCC. Oxytocin is administered prophylactically as it has been shown to significantly decrease the risk or post partum haemorrhage (PPH). PPH occurs in more than 5% of births and is most commonly caused by uterine atony, the failure of the uterus to adequately contract after birth. Oxytocin causes contractions of the uterus, which helps to reduce this risk. In Australia and New Zealand, an intramuscular (IM) or intravenous (IV) injection of Syntocinon ('Registered Trademark'), a synthetic form of the hormone, oxytocin, is administered as the anterior shoulder of the fetus is delivered. There are currently no guidelines indicating how to prophylactically treat PPH during delayed cord clamping. Current standard practice of care allows for the provision of early or delayed cord clamping. however, if cord clamping is delayed a maternal IM injection of 10IU oxytocin is routinely administered with delivery of the anterior shoulder of the fetus. Therefore DCC is currently being performed under the influence of oxytocin without an understanding of the potential effects of uterotonic administration prior to cord clamping on the newborn. This clinical trial aims to determine the effect of maternal IM Syntocinon ('Registered Trademark') administration during delayed umbilical cord clamping on neonatal arterial oxygen saturation (SpO2) and heart rate (HR) at vaginal birth.

Interventions

Delayed cord clamping (90 seconds) with delayed maternal intramuscular injection of 10IU oxytocin within 2 minutes after cord clamping. All procedure and drug administration times logged by study staff on data collection sheet.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

To be eligible to participate in the trial, women must: 1) Over the age of 18 2) Under the age of 50 3) 37 weeks pregnant or more 4) Singleton pregnancy 5) Vaginal birth at term 6) Be capable of understanding the information provided 7) Give written informed consent

Exclusion criteria

Women who meet any of the following criteria at any point during the trial will not be eligible to participate: 1) Multiple gestation 2) Previous post partum haemorrhage (blood loss of >500 mL following vaginal birth or > 750 mL following caesarean section) 3) Detected congenital disorders or intrauterine growth restriction 4) Possession of contraindicating factors for the use of oxytocin 5) Possession of significant risk factors for post partum haemorrhage (e.g. macrosomia >4.5kg, polyhydramnios, abnormal placentation, emergency caesarean section)

Outcome results