A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion at elective caesarean section.

A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000631404

Enrollment

474

Registered

2007-12-12

Start date

2008-03-01

Completion date

2014-04-02

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 double-blind randomised controlled trial, will assess the relative effectiveness of two different oxytocin regimens for the prevention/treatment of haemorrhage after a caesarean section

Interventions

For the management of the third stage of labour at elective caesarean section, a single dose intravenous bolus injection of 5 IU (international units) oxytocin plus 20 IU (international units) oxytocin intravenous infusion (rate 250mls hour infused over 4 hours).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

Pregnancy: Singleton only Fetus: Alive only Gestation: 37 weeks - 41 weeks Surgery: Elective lower segment caesarean section Anaesthesia: Regional anaesthesia (spinal, epidural, combined spinal epidural (CSE)) Past medical history: No significant maternal medical or obstetric disorders Parity: <3 (equal to or less than 3): Pre-op Haemoglobin: "Hb" > (equal to or more than) 100g/dl Language: Fluency in English Age: >18 years of age (equal to or more than)

Exclusion criteria

Active labour (presence of regular uterine activity accompanied by cervical dilation) Emergency caesarean section General anaesthesia (Less than) <37 completed weeks of pregnancy Fetal demise Multiple pregnancy Polyhydramnios Macrosomic fetus (Estimated fetal weight "EFW" >4.5 kg) Past history of post partum haemorrhage 'PPH' requiring additional measures Antepartum haemorrhage (requiring hospitalisation) Known abnormality of placentation (e.g. placenta praevia, vasa, praevia, accreta) Presence of uterine leiomyoma Classical uterine incision (Past history of or intention at this lower segment caesarean section "LUSCS"). Evidence of intrauterine infection e.g. chorioamnionitis Significant maternal medical disorders: Cardiac disease/arrhythmias. Hypertensive disorders: chronic/essential hypertension /pregnancy induced hypertension "PIH"/Pre eclampsia +/- magnesium sulphate "MgSO4" therapy. Known inherited coagulopathies, haemorrhagic/bleeding disorders (family history/known carriers of same) or other abnormalities of coagulation. Currently prescribed anticoagulant medication. Obstetric cholestasis. Connective tissue disorders Past history of ruptured uterus Previous adverse reaction to oxytocin (Syntocinon®)

Outcome results