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Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial
Objective The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in La...
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Published in: | American journal of obstetrics and gynecology 2013-11, Vol.209 (5), p.425.e1-425.e8 |
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creator | Vigil-De Gracia, Paulino, MD Reyes Tejada, Osvaldo, MD Calle Miñaca, Andrés, MD Tellez, Gerardo, MD Chon, Vicente Yuen, MD Herrarte, Edgar, MD Villar, Aurora, MD Ludmir, Jack, MD |
description | Objective The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. Results A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group ( P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34–1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81–1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79–1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21–4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13–22.7; P = .01). There were no maternal deaths. Conclusion This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age. |
doi_str_mv | 10.1016/j.ajog.2013.08.016 |
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Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. Results A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group ( P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34–1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81–1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79–1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21–4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13–22.7; P = .01). There were no maternal deaths. Conclusion This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2013.08.016</identifier><identifier>PMID: 23954534</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Abruptio Placentae - prevention & control ; abruption placentae ; Adult ; Betamethasone - therapeutic use ; Delivery, Obstetric - methods ; Dexamethasone - therapeutic use ; expectant management ; Female ; Gestational Age ; Glucocorticoids - therapeutic use ; Humans ; Infant, Newborn ; Infant, Small for Gestational Age ; Latin America ; Obstetrics and Gynecology ; Perinatal Mortality ; perinatal mortality and morbidity ; Pre-Eclampsia - therapy ; Pregnancy ; severe preeclampsia ; Severity of Illness Index ; Tertiary Care Centers ; Treatment Outcome ; Watchful Waiting - methods ; Young Adult</subject><ispartof>American journal of obstetrics and gynecology, 2013-11, Vol.209 (5), p.425.e1-425.e8</ispartof><rights>Mosby, Inc.</rights><rights>2013 Mosby, Inc.</rights><rights>Copyright © 2013 Mosby, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-a38f87560ff1ef6b995369d2cb01b95123fba72cb23e176430e5b93001f5a65c3</citedby><cites>FETCH-LOGICAL-c411t-a38f87560ff1ef6b995369d2cb01b95123fba72cb23e176430e5b93001f5a65c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23954534$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vigil-De Gracia, Paulino, MD</creatorcontrib><creatorcontrib>Reyes Tejada, Osvaldo, MD</creatorcontrib><creatorcontrib>Calle Miñaca, Andrés, MD</creatorcontrib><creatorcontrib>Tellez, Gerardo, MD</creatorcontrib><creatorcontrib>Chon, Vicente Yuen, MD</creatorcontrib><creatorcontrib>Herrarte, Edgar, MD</creatorcontrib><creatorcontrib>Villar, Aurora, MD</creatorcontrib><creatorcontrib>Ludmir, Jack, MD</creatorcontrib><title>Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Objective The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. Results A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group ( P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34–1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81–1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79–1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21–4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13–22.7; P = .01). There were no maternal deaths. Conclusion This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.</description><subject>Abruptio Placentae - prevention & control</subject><subject>abruption placentae</subject><subject>Adult</subject><subject>Betamethasone - therapeutic use</subject><subject>Delivery, Obstetric - methods</subject><subject>Dexamethasone - therapeutic use</subject><subject>expectant management</subject><subject>Female</subject><subject>Gestational Age</subject><subject>Glucocorticoids - therapeutic use</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Small for Gestational Age</subject><subject>Latin America</subject><subject>Obstetrics and Gynecology</subject><subject>Perinatal Mortality</subject><subject>perinatal mortality and morbidity</subject><subject>Pre-Eclampsia - therapy</subject><subject>Pregnancy</subject><subject>severe preeclampsia</subject><subject>Severity of Illness Index</subject><subject>Tertiary Care Centers</subject><subject>Treatment Outcome</subject><subject>Watchful Waiting - methods</subject><subject>Young Adult</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNp9kUtv1DAUhS0EotPCH2CBvGTRBD_yRAipqqaANBWIgsTOcpzr4hDHwXYqhkV_O46mZdEFq_vQOUe630XoBSU5JbR6PeRycNc5I5TnpMnT6hHaUNLWWdVUzWO0IYSwrOV1c4SOQxjWkbXsKTpivC2LkhcbdLv9PYOKcorYykleg4XUOo0D3IAHPHsANUo7ByOxB-siYO2dxRG8fYPjD8CX2--fv2zxTkYz4au49PtTnLRy6p01f6A_xXYZo1EpGDxWo5mMkiOO3sjxGXqi5Rjg-V09Qd8utl_PP2S7T-8_np_tMlVQGjPJG93UZUW0pqCrrm1LXrU9Ux2hXVtSxnUn6zQyDrSuCk6g7FpOCNWlrErFT9CrQ-7s3a8FQhTWBAXjKCdwSxC0KAlteOKTpOwgVd6F4EGL2Rsr_V5QIlbuYhArd7FyF6QRaZVML-_yl85C_89yDzoJ3h4EkK68MeBFUAYmBb3xib_onfl__rsH9nuOP2EPYXCLnxI_QUVggoir9dXr42li0BSp_Qt2Vqll</recordid><startdate>20131101</startdate><enddate>20131101</enddate><creator>Vigil-De Gracia, Paulino, MD</creator><creator>Reyes Tejada, Osvaldo, MD</creator><creator>Calle Miñaca, Andrés, MD</creator><creator>Tellez, Gerardo, MD</creator><creator>Chon, Vicente Yuen, MD</creator><creator>Herrarte, Edgar, MD</creator><creator>Villar, Aurora, MD</creator><creator>Ludmir, Jack, MD</creator><general>Mosby, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20131101</creationdate><title>Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial</title><author>Vigil-De Gracia, Paulino, MD ; Reyes Tejada, Osvaldo, MD ; Calle Miñaca, Andrés, MD ; Tellez, Gerardo, MD ; Chon, Vicente Yuen, MD ; Herrarte, Edgar, MD ; Villar, Aurora, MD ; Ludmir, Jack, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-a38f87560ff1ef6b995369d2cb01b95123fba72cb23e176430e5b93001f5a65c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Abruptio Placentae - prevention & control</topic><topic>abruption placentae</topic><topic>Adult</topic><topic>Betamethasone - therapeutic use</topic><topic>Delivery, Obstetric - methods</topic><topic>Dexamethasone - therapeutic use</topic><topic>expectant management</topic><topic>Female</topic><topic>Gestational Age</topic><topic>Glucocorticoids - therapeutic use</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Small for Gestational Age</topic><topic>Latin America</topic><topic>Obstetrics and Gynecology</topic><topic>Perinatal Mortality</topic><topic>perinatal mortality and morbidity</topic><topic>Pre-Eclampsia - therapy</topic><topic>Pregnancy</topic><topic>severe preeclampsia</topic><topic>Severity of Illness Index</topic><topic>Tertiary Care Centers</topic><topic>Treatment Outcome</topic><topic>Watchful Waiting - methods</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vigil-De Gracia, Paulino, MD</creatorcontrib><creatorcontrib>Reyes Tejada, Osvaldo, MD</creatorcontrib><creatorcontrib>Calle Miñaca, Andrés, MD</creatorcontrib><creatorcontrib>Tellez, Gerardo, MD</creatorcontrib><creatorcontrib>Chon, Vicente Yuen, MD</creatorcontrib><creatorcontrib>Herrarte, Edgar, MD</creatorcontrib><creatorcontrib>Villar, Aurora, MD</creatorcontrib><creatorcontrib>Ludmir, Jack, MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vigil-De Gracia, Paulino, MD</au><au>Reyes Tejada, Osvaldo, MD</au><au>Calle Miñaca, Andrés, MD</au><au>Tellez, Gerardo, MD</au><au>Chon, Vicente Yuen, MD</au><au>Herrarte, Edgar, MD</au><au>Villar, Aurora, MD</au><au>Ludmir, Jack, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2013-11-01</date><risdate>2013</risdate><volume>209</volume><issue>5</issue><spage>425.e1</spage><epage>425.e8</epage><pages>425.e1-425.e8</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><abstract>Objective The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. Study Design This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. Results A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group ( P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34–1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81–1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79–1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21–4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13–22.7; P = .01). There were no maternal deaths. Conclusion This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>23954534</pmid><doi>10.1016/j.ajog.2013.08.016</doi></addata></record> |
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subjects | Abruptio Placentae - prevention & control abruption placentae Adult Betamethasone - therapeutic use Delivery, Obstetric - methods Dexamethasone - therapeutic use expectant management Female Gestational Age Glucocorticoids - therapeutic use Humans Infant, Newborn Infant, Small for Gestational Age Latin America Obstetrics and Gynecology Perinatal Mortality perinatal mortality and morbidity Pre-Eclampsia - therapy Pregnancy severe preeclampsia Severity of Illness Index Tertiary Care Centers Treatment Outcome Watchful Waiting - methods Young Adult |
title | Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial |
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