A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

Hdl Handle:
http://hdl.handle.net/10147/207989
Title:
A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.
Authors:
Murphy, Deirdre J; MacGregor, Honor; Munishankar, Bhagya; McLeod, Graeme
Affiliation:
Academic Department of Obstetrics & Gynaecology, Coombe Women's Hospital &, Trinity College, University of Dublin, Dublin 8, Ireland. deirdre.j.murphy@tcd.ie
Citation:
Eur J Obstet Gynecol Reprod Biol. 2009 Jan;142(1):30-3. Epub 2008 Nov 5.
Journal:
European journal of obstetrics, gynecology, and reproductive biology
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/207989
DOI:
10.1016/j.ejogrb.2008.09.004
PubMed ID:
18977579
Abstract:
OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.
Language:
eng
MeSH:
Adult; Blood Loss, Surgical/*prevention & control; Cesarean Section/*methods; Female; Humans; Oxytocin/*administration & dosage; Pilot Projects; Placebos; Postpartum Hemorrhage/*prevention & control; Pregnancy; Research Design
ISSN:
1872-7654 (Electronic); 0301-2115 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorMurphy, Deirdre Jen_GB
dc.contributor.authorMacGregor, Honoren_GB
dc.contributor.authorMunishankar, Bhagyaen_GB
dc.contributor.authorMcLeod, Graemeen_GB
dc.date.accessioned2012-02-01T10:56:55Z-
dc.date.available2012-02-01T10:56:55Z-
dc.date.issued2012-02-01T10:56:55Z-
dc.identifier.citationEur J Obstet Gynecol Reprod Biol. 2009 Jan;142(1):30-3. Epub 2008 Nov 5.en_GB
dc.identifier.issn1872-7654 (Electronic)en_GB
dc.identifier.issn0301-2115 (Linking)en_GB
dc.identifier.pmid18977579en_GB
dc.identifier.doi10.1016/j.ejogrb.2008.09.004en_GB
dc.identifier.urihttp://hdl.handle.net/10147/207989-
dc.description.abstractOBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.en_GB
dc.language.isoengen_GB
dc.subject.meshAdulten_GB
dc.subject.meshBlood Loss, Surgical/*prevention & controlen_GB
dc.subject.meshCesarean Section/*methodsen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshHumansen_GB
dc.subject.meshOxytocin/*administration & dosageen_GB
dc.subject.meshPilot Projectsen_GB
dc.subject.meshPlacebosen_GB
dc.subject.meshPostpartum Hemorrhage/*prevention & controlen_GB
dc.subject.meshPregnancyen_GB
dc.subject.meshResearch Designen_GB
dc.titleA randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.en_GB
dc.contributor.departmentAcademic Department of Obstetrics & Gynaecology, Coombe Women's Hospital &, Trinity College, University of Dublin, Dublin 8, Ireland. deirdre.j.murphy@tcd.ieen_GB
dc.identifier.journalEuropean journal of obstetrics, gynecology, and reproductive biologyen_GB
dc.description.provinceLeinster-
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