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

Phase 4

• Conditions: Postpartum haemorrhage; Elective caesarean section; Uterine atony; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12607000631404
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 948

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®)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for additional uterotonic measures[24 hours postpartum]

Secondary Outcome Measures

Name	Time	Method
Volume of fluid (crystalloid/colloid) replacement required to correct hypovolaemia.[Prior to discharge];Number of women administered blood products (packed red cells, platelets, fresh frozen plasma).[Prior to discharge];A return to theatre within 24 hours in order to arrest bleeding/haemorrhage.[24 hours];A change in postnatal day 1 haemoglobin (Hb) (compared to preoperative measurement).[24 hours];Composite serious maternal morbidity/mortality (Admission to High Dependency Unit/Intensive Care Unit HDU/ITU, Prolonged postnatal stay (> 5 days), hysterectomy, haematologic dysfunction (e.g disseminated intravascular coagulation, laparotomy, blood loss >1,000mls, death[Prior to discharge]