Low dose versus standard dose oxytocin in pregnant women undergoing elective caesarean delivery

Effect of 3 units versus 5 units slow intravenous bolus oxytocin on postpartum blood loss in women undergoing elective caesarean delivery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000398404

Enrollment

Registered

2016-03-29

Start date

2011-07-18

Completion date

2013-05-27

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

This study sought to determine whether 3IU oxytocin was comparable to standard 5IU regarding postpartum blood loss in pregnant women undergoing elective caesarean delivery under spinal anaesthetic, but could reduce blood pressure elevating medication (vasopressor) requirements and adverse events. We hypothesized that patients receiving 3IU oxytocin would be non-inferior to 5IU regarding postpartum blood loss and superior regarding uterine tone, incidence of low blood pressure (hypotension), blood pressure elevating medication (vasopressor) requirements and adverse events.

Interventions

Slow bolus intravenous injection of 3 units oxytocin administered by anaesthetist over 60 seconds at the time of delivery.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

ASA I –II, term pregnancy (>38 weeks), aged 18 to 40 years and scheduled for elective caesarean delivery.

Exclusion criteria

Clinical history of hypertensive disorders (pre eclampsia; chronic hypertension), haemodynamic instability (systolic blood pressure < 100 mmHg), bleeding diastasis (thrombocytopenia, coagulopathies) and history of uterine atony causing post-partum haemorrhage.

Outcome results