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.
Monash University
948 participants
Mar 1, 2008
Interventional
Conditions
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
Eligibility
Inclusion Criteria1
- 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 Criteria17
- 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®)
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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).
Locations(1)
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ACTRN12607000631404