Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

Hdl Handle:
http://hdl.handle.net/10147/208017
Title:
Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.
Authors:
Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R
Affiliation:
Obstetrics & Gynaecology, Coombe Women and Infants University Hospital, Trinity, College Dublin, Dublin 8, Ireland. deirdre.j.murphy@tcd.ie
Citation:
BMC Pregnancy Childbirth. 2009 Aug 24;9:36.
Journal:
BMC pregnancy and childbirth
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/208017
DOI:
10.1186/1471-2393-9-36
PubMed ID:
19703279
Abstract:
BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at elective caesarean section. Safe operative delivery is now a priority and a reality for many pregnant women. Obstetricians, obstetric anaesthetists, midwives and pregnant women need high quality evidence on which to base management approaches. The overall aim is to reduce maternal haemorrhagic morbidity and its attendant risks at elective caesarean section. TRIAL REGISTRATION: number: ISRCTN17813715.
Language:
eng
MeSH:
Adult; Anemia/etiology/prevention & control; Blood Loss, Surgical/*prevention & control; Cesarean Section/adverse effects/*methods; Clinical Protocols; Drug Administration Schedule; Feasibility Studies; Female; Humans; Oxytocics/*administration & dosage; Oxytocin/*administration & dosage; Patient Selection; Pilot Projects; Pregnancy; Research Design; Sample Size; Surgical Procedures, Elective/adverse effects/*methods; Time Management; Young Adult
ISSN:
1471-2393 (Electronic); 1471-2393 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorMurphy, Deirdre Jen_GB
dc.contributor.authorCarey, Michaelen_GB
dc.contributor.authorMontgomery, Alan Aen_GB
dc.contributor.authorSheehan, Sharon Ren_GB
dc.date.accessioned2012-02-01T10:57:48Z-
dc.date.available2012-02-01T10:57:48Z-
dc.date.issued2012-02-01T10:57:48Z-
dc.identifier.citationBMC Pregnancy Childbirth. 2009 Aug 24;9:36.en_GB
dc.identifier.issn1471-2393 (Electronic)en_GB
dc.identifier.issn1471-2393 (Linking)en_GB
dc.identifier.pmid19703279en_GB
dc.identifier.doi10.1186/1471-2393-9-36en_GB
dc.identifier.urihttp://hdl.handle.net/10147/208017-
dc.description.abstractBACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at elective caesarean section. Safe operative delivery is now a priority and a reality for many pregnant women. Obstetricians, obstetric anaesthetists, midwives and pregnant women need high quality evidence on which to base management approaches. The overall aim is to reduce maternal haemorrhagic morbidity and its attendant risks at elective caesarean section. TRIAL REGISTRATION: number: ISRCTN17813715.en_GB
dc.language.isoengen_GB
dc.subject.meshAdulten_GB
dc.subject.meshAnemia/etiology/prevention & controlen_GB
dc.subject.meshBlood Loss, Surgical/*prevention & controlen_GB
dc.subject.meshCesarean Section/adverse effects/*methodsen_GB
dc.subject.meshClinical Protocolsen_GB
dc.subject.meshDrug Administration Scheduleen_GB
dc.subject.meshFeasibility Studiesen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshHumansen_GB
dc.subject.meshOxytocics/*administration & dosageen_GB
dc.subject.meshOxytocin/*administration & dosageen_GB
dc.subject.meshPatient Selectionen_GB
dc.subject.meshPilot Projectsen_GB
dc.subject.meshPregnancyen_GB
dc.subject.meshResearch Designen_GB
dc.subject.meshSample Sizeen_GB
dc.subject.meshSurgical Procedures, Elective/adverse effects/*methodsen_GB
dc.subject.meshTime Managementen_GB
dc.subject.meshYoung Adulten_GB
dc.titleStudy protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.en_GB
dc.contributor.departmentObstetrics & Gynaecology, Coombe Women and Infants University Hospital, Trinity, College Dublin, Dublin 8, Ireland. deirdre.j.murphy@tcd.ieen_GB
dc.identifier.journalBMC pregnancy and childbirthen_GB
dc.description.provinceLeinster-

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