Effect of a collector bag for measurement of postpartum blood loss after vaginal delivery: cluster randomised trial in 13 European countriesBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c293 (Published 01 February 2010) Cite this as: BMJ 2010;340:c293
- Wei-Hong Zhang, senior researcher1,
- Catherine Deneux-Tharaux, senior researcher2,
- Peter Brocklehurst, professor of perinatal epidemiology3,
- Edmund Juszczak, senior medical statistician3,
- Matthew Joslin, general practitioner1,
- Sophie Alexander, professor of public health1
- on behalf of the EUPHRATES Group
- 1Perinatal Epidemiology Research Unit, School of Public Health, Université Libre de Bruxelles, Route de Lennik 808, CP 597, B-1070 Bruxelles, Belgium
- 2INSERM, UMR S953, UPMC, Epidemiological Research Unit on Perinatal Health and Women’s and Children’s Health, Paris, France
- 3National Perinatal Epidemiology Unit, University of Oxford, Oxford
- Correspondence to: W-H Zhang
- Accepted 27 November 2009
Objective To evaluate the effectiveness of the systematic use of a transparent plastic collector bag to measure postpartum blood loss after vaginal delivery in reducing the incidence of severe postpartum haemorrhage.
Design Cluster randomised trial.
Setting 13 European countries.
Participants 78 maternity units and 25 381 women who had a vaginal delivery.
Interventions Maternity units were randomly assigned to systematic use of a collector bag (intervention group) or to continue to visually assess postpartum blood loss after vaginal delivery (control group).
Main outcome measures The primary outcome was the incidence of severe postpartum haemorrhage in vaginal deliveries, defined as a composite of one or more of blood transfusion, intravenous plasma expansion, arterial embolisation, surgical procedure, admission to an intensive care unit, treatment with recombinant factor VII, and death.
Results Severe postpartum haemorrhage occurred in 189 of 11 037 of vaginal deliveries (1.71%) in the intervention group compared with 295 of 14 344 in the control group (2.06%). The difference was not statistically significant either in individual level analysis (adjusted odds ratio 0.82, 95% confidence interval 0.26 to 2.53) or in cluster level analysis (difference in weighted mean rate adjusted for baseline rate 0.16%, 95% confidence interval −0.69% to 1.02%).
Conclusion Compared with visual estimation of postpartum blood loss the use of a collector bag after vaginal delivery did not reduce the rate of severe postpartum haemorrhage.
Trial registration Current Controlled Trials ISRCTN66197422.
We thank Allan Donner (Canada) and Pierre Buekens (USA) for their scientific advice and Stéphane Freze and Myriam Loubriat for their contribution to collecting and cleaning the data. The following are members of EUPHRATES (EUropean Project on obstetric Haemorrhage, Reduction, Attitudes, Trial and Early warning System): Sophie Alexander (project leader, Belgium), Diogo Ayres-de-Campos (Portugal), Istvan Berbik (Hungary), Marie-Hélène Bouvier-Colle (France), Gérard Bréart (France), Peter Brocklehurst (UK), Vicenç Cararach (Spain), Anna Maria Marconi (Italy), Catherine Deneux-Tharaux (France), Risto Erkkola (Finland), Mathias Klein (Austria), Jens Langhoff-Roos (Denmark), Alison Macfarlane (UK), Walter Prendiville (Republic of Ireland), Jos van Roosmalen (Netherlands), Babill Stray-Pedersen (Norway), Carolyn Troeger (Switzerland), Clare Winter (UK), and Wei-Hong Zhang (Belgium). Also see web extra for a list of people who helped in each country. The following people helped run the trial in their own country: Austria: coordination—Sylvia Artner-Matuschek, Adolf Beck, Daniela Meger David; KH Ried—Penzinger Monika; LKH Bad Ischl—Carola Fuschlberger-Traxler; LKH Heinz Klagenfurt—Leipold; Hanusch KH—Daniela Meger David; AKH University—Hans Helmer, Katharina Klein; LKH Kufstein—Andrea Ehm. Belgium: Ambroise Paré (Mons)—Gilles Ceysens, Annick Nouls, Yaacoub Salame, Linda Van Lierde; Ath—Françoise Clerquin, Pierre Delvoye, Jean Piret; UZ Gent—Paul Defoort, Marleen Temmerman; AZ VUB (Brussels)—Maria Breugelmans, Lieve Devalckeneer, Monika Laubach; Baudour—Joël Annet, Renaud Paquay, Valérie Vandenbosch; Brugmann (Brussels)—Thomas Pezin, Alain Vokaer; Erasme (Brussels)—Christine Kirkpatrick, Anne Maas; Hopital St Pierre (Brussels)—Patricia Barlow, Julie Belhomme, Nordine Ben Ali, Daniel Murillo; Ieper—Colette Berten, Geert Page; Ixelles (Brussels)—Véronique Ziereisen; KUL (Leuven)—Bernadette Bijnens, Bernard Spitz, Joske Timmermans; St Jean (Brussels)—Xavier de Muylder, Christine Stoop; Ste Anne & St Remi (Brussels)—Paul Befahy, Anne Fostier; Tivoli—Maria Fabbricattore, Jacques Francotte, Sylvie Hollemaert; Tournai IMC—Viviane Gadenne; Vésale (Charleroi)—Patrick De Nayer, Didier Oberweiss. Denmark: coordination—Ane Rom, Birgitte Rode Diness; Gentofte Hospital—Anne Barfoed; Glostrup—Ambika Ravn; Hillerød- Gitte Ulriksen; Slagelse—Karen Marie Wigh Felsen; Holbæk—Marianne Brandstrup Larsen; Frederiksberg—Ane Rom. Finland: Helsinki University Central Hospital—Vedran Stefanovic; Midwifery Institute of Helsinki—Veli-Matti Ulander; University central hospital of Turku—Risto Erkkola; University Hospital of Tampere-Jukka Uotila. France: Moulin Hospital—Michel Beytout, Catherine Damouret; University Hospital (Nancy)—Brigitte Guillemain; Antoine Béclère; University Hospital (Clamart)—Aurélia Chauveaud; Tenon University Hospital (Paris)—Nadia Berkane, Marie-Christine Chaux; University Hospital (Rouen)—Loic Marpeau, Sabine Sionville; Villleneuve St Georges Hospital—Patricia Tran van. Hungary: coordination—István Szabó; Baranya County Hospital (Pécs)—József Bódis; City Hospital (Mosonmagyaróvár)—István Barcza; Erzsébet Hospital (Sopron)— Károly Péter Csécsei; Petz Aladár Teaching Hospital (Győr)—Sándor Gardó; Selye János Hospital (Komárom)—László Rokay; Szent Borbála Hospital (Tatabánya)—Mihály Molnár; University Hospital (Sci. Univ. Pécs)—István Szabó, Tamás Csermely; Vaszary Kolos Teaching Hospital (Esztergom)—István Berbik. Ireland: coordination—Reem Akkawi, Fidelma Cavanagh; Coombe Women’s Hospital (Dublin)—Suzanne Kelly; Our Lady of Lourdes (Drogheda)—Dalia Sikafi, Ann Keating; Cavan General Hospital—Iram Basit, Marie McCusker; Midland Regional Hospital Mullingar—Mary Corbet. Italy: Luigi Chiechi at start of project (Bari), then Valentina Mariotti (Milano). Az SS Antonio e Biagio e C Arrigo, Alexenderia—Enrico Rovetta; Osp di Bassano del Grappa(VI)—Yoram Meir; Osp Civile San Paolo, Civitavecchia—Antonio Castellano; Osp Civile S Liberatore, Atri (TE)—Claudio Angeloni; Osp San Massimo, Penne (PE)—Quirino Di Nisio; Pres Osp Di Piove Di Sacco (PD)—Antonino Oro. Netherlands: coordination—Marlies Rijnders, Esteriek de Miranda; St Lucas Hospital; Bronovo Hospital. Norway: coordination—Bente Rønnes, Rikshospitalet, Oslo University Hospital;Sykehuset Innlandet; Gjovik—Anne Kari Gjestvang, Elham Mahjoob; Sykehuset Innlandet Elverum—Agneta Stramrud. Portugal: Coordination—Maria Fatima Oliveira, Cristina Ferreirinha; Maternidade Bissaya Barreto (Coimbra)—Ascenção Baía ; Maternidade Daniel de Matos (Coimbra)—José Portugal; H. S. Marcos (Braga)—Lucília Guerra Sousa: H. S. Joao (Porto)—Cristina Ferreirinha; Senhora da Oliveira (Guimaraes)—Alice Santos. Spain: coordination—Sonia Pisa, Sara Herrero; H. Clínic—Enrique Barrau, Jordi Bellart, Isabel Salgado; H. Vall d’Hebró—Anna Suy; H. Sabadell—Jordi Costa, Maria Grimau; H. Joan XXIII—Ramón Mª Miralles; H. del Mar—Antoni Payà; H. San Joan de Deu—Sergi Cabré; H. Sant Pau—Marta Simó; H. Germans Trias—José Lecumberri. Switzerland: coordination —Irene Hösli, Gideon Sartorius; Aarau-Monya Todesco; Basel—Gideon Sartorius; Frauenfeld—Verena Geissbühler; Fribourg—David Stucki, Heidrun Schönberger; Solothurn—Suzanne Zakher; St Gallen—Gero Drack, Anika Hey-Moonen.
Contributors: W-HZ designed data collection tools, monitored data collection for the whole trial, wrote the statistical analysis plan, cleaned and analysed the data, and drafted and revised the paper. She is guarantor. CD-T implemented the trial in France, analysed the data, and drafted and revised the paper. PB analysed the data and drafted and revised the paper. EJ wrote the statistical analysis plan, monitored data collection for the whole trial, and revised the draft paper. MJ designed data collection tools,, monitored data collection for the whole trial, and revised the draft paper. SA initiated the collaborative project, designed data collection tools, implemented the trial for the all countries, monitored data collection for the whole trial, analysed the data, and drafted and revised the paper. All members of EUPHRATES designed the trial. Diogo Ayres-de-Campos, Istvan Berbik, Marie-Hélène Bouvier-Colle, Vicenç Cararach, Risto Erkkola, Mathias Klein, Walter Prendiville, Jos van Roosmalen, Babill Stray-Pedersen, and Carolyn Troeger implemented the trial in, respectively, Portugal, Hungary, France, Spain, Finland, Austria, Republic of Ireland, Netherlands, Norway, and Switzerland, and revised the draft paper. Gérard Bréart analysed the data and revised the draft paper. Alison Macfarlane and Clare Winter revised the draft paper.
Funding: W-HZ received a grant from Fondation Philippe Wiener-Maurice Anspach for the final analysis of the data. The project was funded by the European Union under framework 5 (contract QLG4-CT-2001-01352). The EU had no role in the design, management, data collection, analyses, or interpretation of the data or in the writing of the manuscript or the decision to submit for publication.
Competing interests: None declared.
Ethical approval: Ethical approval was obtained in each country from relevant local or national research ethics committees. Consent to participate was obtained from the maternity units. Because the procedure being tested was not invasive or different from current clinical practice, and because outcome data were routinely collected at maternity units and anonymously transmitted, no individual consent was sought.
Data sharing: No additional data are available.
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