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Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study)
Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy. We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. In four Dutch h...
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description | Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy. We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle. From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups. Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation. |
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(REFILL study)</title><source>PubMed Central Free</source><source>ProQuest Publicly Available Content database</source><creator>Schol, Pim B. B ; de Lange, Natascha M ; Woiski, Mallory D ; Langenveld, Josje ; Smits, Luc J. M ; Wassen, Martine M ; Henskens, Yvonne M ; Scheepers, Hubertina C. J</creator><contributor>Ducarme, Guillaume</contributor><creatorcontrib>Schol, Pim B. B ; de Lange, Natascha M ; Woiski, Mallory D ; Langenveld, Josje ; Smits, Luc J. M ; Wassen, Martine M ; Henskens, Yvonne M ; Scheepers, Hubertina C. J ; Ducarme, Guillaume</creatorcontrib><description>Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy. We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle. From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups. Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0253765</identifier><identifier>PMID: 34170943</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Acidosis ; Biology and Life Sciences ; Blood ; Blood coagulation ; Blood pressure ; Blood transfusion ; Care and treatment ; Childbirth ; Childbirth & labor ; Clinical trials ; Coagulation ; Complications and side effects ; Gynecology ; Health risks ; Hemoglobin ; Hemorrhage ; Hypothermia ; Intensive care ; Medicine and Health Sciences ; Methods ; Obstetrics ; Parameters ; Patients ; Placenta ; Postnatal care ; Pre-eclampsia ; Pregnancy ; Research and Analysis Methods ; Resuscitation ; Transfusion ; Vagina ; Womens health</subject><ispartof>PloS one, 2021-06, Vol.16 (6), p.e0253765-e0253765</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Schol et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups. Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. 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B</au><au>de Lange, Natascha M</au><au>Woiski, Mallory D</au><au>Langenveld, Josje</au><au>Smits, Luc J. M</au><au>Wassen, Martine M</au><au>Henskens, Yvonne M</au><au>Scheepers, Hubertina C. J</au><au>Ducarme, Guillaume</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study)</atitle><jtitle>PloS one</jtitle><date>2021-06-25</date><risdate>2021</risdate><volume>16</volume><issue>6</issue><spage>e0253765</spage><epage>e0253765</epage><pages>e0253765-e0253765</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy. We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle. From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups. Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>34170943</pmid><doi>10.1371/journal.pone.0253765</doi><tpages>e0253765</tpages><orcidid>https://orcid.org/0000-0002-6486-4508</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Acidosis Biology and Life Sciences Blood Blood coagulation Blood pressure Blood transfusion Care and treatment Childbirth Childbirth & labor Clinical trials Coagulation Complications and side effects Gynecology Health risks Hemoglobin Hemorrhage Hypothermia Intensive care Medicine and Health Sciences Methods Obstetrics Parameters Patients Placenta Postnatal care Pre-eclampsia Pregnancy Research and Analysis Methods Resuscitation Transfusion Vagina Womens health |
title | Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study) |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T09%3A07%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Restrictive%20versus%20liberal%20fluid%20resuscitation%20strategy,%20influence%20on%20blood%20loss%20and%20hemostatic%20parameters%20in%20mild%20obstetric%20hemorrhage:%20An%20open-label%20randomized%20controlled%20trial.%20(REFILL%20study)&rft.jtitle=PloS%20one&rft.au=Schol,%20Pim%20B.%20B&rft.date=2021-06-25&rft.volume=16&rft.issue=6&rft.spage=e0253765&rft.epage=e0253765&rft.pages=e0253765-e0253765&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0253765&rft_dat=%3Cgale_plos_%3EA666439567%3C/gale_plos_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c669t-be0ddf208936a31a88226be8d06dbb25c2d0dbb9e3a57f3781bc77367149dc563%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2545225178&rft_id=info:pmid/34170943&rft_galeid=A666439567&rfr_iscdi=true |