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

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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

Related collections

Most cited references 19

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Oxytocin requirements at elective cesarean delivery: a dose-finding study.

Luiz J. C. B. Carvalho, John C. Kingdom, Mrinalini Balki … (2004)

Oxytocin is frequently used by intravenous bolus and infusion to minimize blood loss and prevent postpartum hemorrhage at cesarean delivery. Current dosing regimens are arbitrary whereas large doses may pose a serious risk to the mother. The purpose of this study was to estimate the minimum effective intravenous bolus dose of oxytocin (ED90) required for adequate uterine contraction at elective cesarean in nonlaboring women. A randomized, single-blinded study was undertaken in 40 healthy term pregnant women presenting for elective cesarean under spinal anesthesia. Oxytocin was administered by bolus according to a biased coin up-and-down sequential allocation scheme with increments or decrements of 0.5 IU. Uterine contraction was assessed by the obstetrician, who was blinded to the dose of oxytocin, as either satisfactory or unsatisfactory. After achieving sustained uterine contraction, an infusion of 40 mU/min of oxytocin was started. Oxytocin-induced adverse effects and intraoperative complications were recorded and blood loss was estimated. Data were interpreted by parametric analysis based on logistic regression model and nonparametric analyses at 95% confidence intervals (CIs). The ED90 of oxytocin as determined by logistic regression model fitted to the data was estimated to be 0.35 IU (95% CI 0.18-0.52 IU), with nonparametric estimates of 97.1% (95% CI 84.9-99.8%) response rate at 0.5 IU, and 100% (95% CI 92.2-100%) at 1.0 IU. The estimated blood loss was 693 +/- 487 mL (mean +/- standard deviation). The bolus dose of oxytocin used at elective cesarean deliveries in nonlaboring women can be significantly reduced while maintaining effective uterine contraction. Alteration in practice will likely reduce the potential adverse effects of this drug when given in large bolus doses, but may require modification of the techniques to remove the placenta.

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Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section.

Jerome Dansereau, Arvind K. Joshi, Michael E Helewa … (1999)

The goal of this study was to compare carbetocin, a long-acting oxytocin analog, with oxytocin in the prevention of uterine atony after cesarean section. We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter, double-blind, randomized clinical trial. We compared the effect of a single 100 microg dose of carbetocin with that of a standard 8-hour infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. A variable sample size, sequential design was used. The overall oxytocic intervention rate was 7.4%. The odds of treatment failure requiring oxytocic intervention was 2.03 (95% confidence interval 1.1 to 2.8) times higher in the oxytocin group compared with the carbetocin group, respectively, 32 of 318 (10.1%) versus 15 of 317 (4.7%), P <.05. Carbetocin, a new drug for the prevention of uterine atony, appears to be more effective than a continuous infusion of oxytocin and has a similar safety profile.

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Increased cesarean section rates and emerging patterns of health insurance in Shanghai, China.

J. Marks, Y. Zhuang, Reuben Harris … (1998)

This study examined the trend in cesarean section deliveries and the factors associated with it in the Minhang District of Shanghai, China. A representative sample of the members of 2716 households in the district were interviewed in the fall of 1993. This study analyzed the data from 1959 married women of reproductive age with at least one live birth. During the past 3 decades, the proportion of infants born by cesarean section increased from 4.7% to 22.5%. Logistic regression analysis revealed that the highest cesarean section rate, which occurred in the most recent period of 1988 through 1993, was associated with form of medical payment, self-reported complications during pregnancy, higher birthweight, and maternal age. Government insurance pays all costs of cesarean sections and accounted for the highest proportion of the cesarean section rate. The high rates of cesarean sections in China are surprising given the lack of the factors that usually lead to cesarean sections. The increasing cesarean section rates may be an early indication that emerging forms of health insurance and fee-for-service payments to physicians will lead to an excessive emphasis on costly, high-technology medical care in China.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Pregnancy Childbirth

Title: BMC Pregnancy and Childbirth

Publisher: BioMed Central

ISSN (Electronic): 1471-2393

Publication date Collection: 2009

Publication date (Electronic): 24 August 2009

Volume: 9

Page: 36

Affiliations

[1 ]Obstetrics & Gynaecology, Coombe Women and Infants University Hospital, Trinity College Dublin, Dublin 8, Ireland

[2 ]Anaesthetics & Peri-operative Medicine, Coombe Women and Infants University Hospital, Dublin 8, Ireland

[3 ]Primary Care Research, Department of Community Based Medicine, University of Bristol, 25 Belgrave Road, Bristol, BS8 2AA, UK

[4 ]Coombe Women and Infants University Hospital, Trinity College Dublin, Dublin 8, Ireland

Article

Publisher ID: 1471-2393-9-36

DOI: 10.1186/1471-2393-9-36

PMC ID: 2739153

PubMed ID: 19703279

SO-VID: 8290c7fa-6e4e-4db4-9a5f-e0c9fd9faf80

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.