Comparison of the efficacy of oxtyocin agonist to oxytocin in the prevention of postpartum hemorrhage (PPH) in women undergoing vaginal delivery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000396325

Enrollment

720

Registered

2008-08-05

Start date

2006-12-13

Completion date

Unknown

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 is intended to compare the efficacy and safety of an oxytocin analogue and oxytocin in the prevention of postpartum hemorrhage (massive bleeding after birth) in women undergoing vaginal delivery. Oxytocin and its analogue are drugs used to contract the uterus to prevent postpartum hemorrhage. We would like to compare the effect of the drugs to lower the need for additional intervention (additional massage or other uterotonic needed) in the prevention of PPH postpartum hemorrhage.

Interventions

For the management of 3rd stage of labour at vaginal delivery, 100 microgram Intramuscular (IM) slow bolus injection of oxytocin agonist after infant is delivered

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

Normal and healthy women who will undergo vaginal delivery, Parity I-IV, Singleton pregnancy with cephalic presentation

Exclusion criteria

Primigravida or Para V and above, History of PPH and/or uterine atony in the previous delivery, History of cardiac arrhythmia or any other clinically significant heart diseases, History of hypertension requiring treatment within the last 2 years, History of anaemia (Hb <10 g/dL), Known or suspected coagulopathy (hereditary or acquired) (eg. von Willebrand’s disease, etc), History or evidence of chronic liver, renal or endocrine disease, History of hypersensitivity to oxytocin or carbetocin, Placenta previa or abruptio placentae, Any sign of pre-existing uterine pathology or anomaly, Rupture of membrane

Outcome results