Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)
Background Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical pessa...
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| Veröffentlicht in: | American journal of obstetrics and gynecology 2016-02, Vol.214 (2), p.145-152 |
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| creator | Goya, Maria, MD, PhD de la Calle, Maria, MD, PhD Pratcorona, Laia, MD Merced, Carme, MD Rodó, Carlota, MD Muñoz, Begoña, MD, PhD Juan, Miquel, MD Serrano, Ariana, MD Llurba, Elisa, MD, PhD Higueras, Teresa, MD, PhD Carreras, Elena, MD, PhD Cabero, Luis, MD, PhD |
| description | Background Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. Study Design A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov , number NCT01242410 . Eligible women were scanned in Spain. The primary outcome was SPB |
| doi_str_mv | 10.1016/j.ajog.2015.11.012 |
| format | Article |
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In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. Study Design A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov , number NCT01242410 . Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated. Results Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g ( P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed. Conclusion The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2015.11.012</identifier><identifier>PMID: 26627728</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; cervical length ; Cervical Length Measurement ; Cervix Uteri - diagnostic imaging ; Chorioamnionitis - epidemiology ; Female ; Fetal Membranes, Premature Rupture - epidemiology ; Hospitalization - statistics & numerical data ; Humans ; Infant, Low Birth Weight ; Infant, Newborn ; Length of Stay ; neonatal morbidity and mortality ; Obstetrics and Gynecology ; Pessaries ; Pregnancy ; Pregnancy, Twin ; Premature Birth - prevention & control ; prematurity ; preterm birth ; short cervix ; Spain ; Tocolysis - utilization ; Treatment Outcome ; twins</subject><ispartof>American journal of obstetrics and gynecology, 2016-02, Vol.214 (2), p.145-152</ispartof><rights>Elsevier Inc.</rights><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-35e96f81f24b7d63633a0d83850229d72886d21073f57a7e5563e77f9f044b563</citedby><cites>FETCH-LOGICAL-c411t-35e96f81f24b7d63633a0d83850229d72886d21073f57a7e5563e77f9f044b563</cites><orcidid>0000-0003-4001-2017</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002937815023170$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26627728$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Goya, Maria, MD, PhD</creatorcontrib><creatorcontrib>de la Calle, Maria, MD, PhD</creatorcontrib><creatorcontrib>Pratcorona, Laia, MD</creatorcontrib><creatorcontrib>Merced, Carme, MD</creatorcontrib><creatorcontrib>Rodó, Carlota, MD</creatorcontrib><creatorcontrib>Muñoz, Begoña, MD, PhD</creatorcontrib><creatorcontrib>Juan, Miquel, MD</creatorcontrib><creatorcontrib>Serrano, Ariana, MD</creatorcontrib><creatorcontrib>Llurba, Elisa, MD, PhD</creatorcontrib><creatorcontrib>Higueras, Teresa, MD, PhD</creatorcontrib><creatorcontrib>Carreras, Elena, MD, PhD</creatorcontrib><creatorcontrib>Cabero, Luis, MD, PhD</creatorcontrib><creatorcontrib>PECEP-Twins Trial Group</creatorcontrib><title>Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Background Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. Study Design A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov , number NCT01242410 . Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated. Results Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g ( P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed. Conclusion The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.</description><subject>Adult</subject><subject>cervical length</subject><subject>Cervical Length Measurement</subject><subject>Cervix Uteri - diagnostic imaging</subject><subject>Chorioamnionitis - epidemiology</subject><subject>Female</subject><subject>Fetal Membranes, Premature Rupture - epidemiology</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Humans</subject><subject>Infant, Low Birth Weight</subject><subject>Infant, Newborn</subject><subject>Length of Stay</subject><subject>neonatal morbidity and mortality</subject><subject>Obstetrics and Gynecology</subject><subject>Pessaries</subject><subject>Pregnancy</subject><subject>Pregnancy, Twin</subject><subject>Premature Birth - prevention & control</subject><subject>prematurity</subject><subject>preterm birth</subject><subject>short cervix</subject><subject>Spain</subject><subject>Tocolysis - utilization</subject><subject>Treatment Outcome</subject><subject>twins</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9Us1u1DAYjBCILoUX4IB8LIcE_2zsBCEktNoCUiUqUc6W1_my65DYi-1sKQ9T9Vn6ZNjawoEDF38aab6RZ-YripcEVwQT_mao1OC2FcWkrgipMKGPigXBrSh5w5vHxQJjTMuWieakeBbCkCFt6dPihHJOhaDNorhdgT8YrUa0hxCUv0HRob2HA9iYZwQ_oY3xcYeMRddugvSahOJ1wlsIUUXj7P2dsh0KzrqtV_ud0SjsnI9IZ_Wfb5FC0zxGo5MqeOQT2U3mF3T3d9rZ6N04QoeiN-kfZ5fr1fqyvEr64fXz4kmvxgAvHuZp8e18fbX6VF58-fh59eGi1EtCYslqaHnfkJ4uN6LjjDOmcNewps6Ou-S04R0lWLC-FkpAXXMGQvRtj5fLTQKnxdlRd-_djzm5kpMJGsZRWXBzkERwJnCKjCQqPVK1dyF46OXemyklJwmWuRc5yNyLzL1IQmTqJS29etCfNxN0f1f-FJEI744ESC4PBrwM2oDV0BkPOsrOmf_rv_9nXY_G5l6_ww2Ewc3epvwkkYFKLL_mU8iHQVJAjAjMfgNDpbb3</recordid><startdate>20160201</startdate><enddate>20160201</enddate><creator>Goya, Maria, MD, PhD</creator><creator>de la Calle, Maria, MD, PhD</creator><creator>Pratcorona, Laia, MD</creator><creator>Merced, Carme, MD</creator><creator>Rodó, Carlota, MD</creator><creator>Muñoz, Begoña, MD, PhD</creator><creator>Juan, Miquel, MD</creator><creator>Serrano, Ariana, MD</creator><creator>Llurba, Elisa, MD, PhD</creator><creator>Higueras, Teresa, MD, PhD</creator><creator>Carreras, Elena, MD, PhD</creator><creator>Cabero, Luis, MD, PhD</creator><general>Elsevier 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><orcidid>https://orcid.org/0000-0003-4001-2017</orcidid></search><sort><creationdate>20160201</creationdate><title>Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)</title><author>Goya, Maria, MD, PhD ; de la Calle, Maria, MD, PhD ; Pratcorona, Laia, MD ; Merced, Carme, MD ; Rodó, Carlota, MD ; Muñoz, Begoña, MD, PhD ; Juan, Miquel, MD ; Serrano, Ariana, MD ; Llurba, Elisa, MD, PhD ; Higueras, Teresa, MD, PhD ; Carreras, Elena, MD, PhD ; Cabero, Luis, MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-35e96f81f24b7d63633a0d83850229d72886d21073f57a7e5563e77f9f044b563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>cervical length</topic><topic>Cervical Length Measurement</topic><topic>Cervix Uteri - diagnostic imaging</topic><topic>Chorioamnionitis - epidemiology</topic><topic>Female</topic><topic>Fetal Membranes, Premature Rupture - epidemiology</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Humans</topic><topic>Infant, Low Birth Weight</topic><topic>Infant, Newborn</topic><topic>Length of Stay</topic><topic>neonatal morbidity and mortality</topic><topic>Obstetrics and Gynecology</topic><topic>Pessaries</topic><topic>Pregnancy</topic><topic>Pregnancy, Twin</topic><topic>Premature Birth - prevention & control</topic><topic>prematurity</topic><topic>preterm birth</topic><topic>short cervix</topic><topic>Spain</topic><topic>Tocolysis - utilization</topic><topic>Treatment Outcome</topic><topic>twins</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Goya, Maria, MD, PhD</creatorcontrib><creatorcontrib>de la Calle, Maria, MD, PhD</creatorcontrib><creatorcontrib>Pratcorona, Laia, MD</creatorcontrib><creatorcontrib>Merced, Carme, MD</creatorcontrib><creatorcontrib>Rodó, Carlota, MD</creatorcontrib><creatorcontrib>Muñoz, Begoña, MD, PhD</creatorcontrib><creatorcontrib>Juan, Miquel, MD</creatorcontrib><creatorcontrib>Serrano, Ariana, MD</creatorcontrib><creatorcontrib>Llurba, Elisa, MD, PhD</creatorcontrib><creatorcontrib>Higueras, Teresa, MD, PhD</creatorcontrib><creatorcontrib>Carreras, Elena, MD, PhD</creatorcontrib><creatorcontrib>Cabero, Luis, MD, PhD</creatorcontrib><creatorcontrib>PECEP-Twins Trial Group</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>Goya, Maria, MD, PhD</au><au>de la Calle, Maria, MD, PhD</au><au>Pratcorona, Laia, MD</au><au>Merced, Carme, MD</au><au>Rodó, Carlota, MD</au><au>Muñoz, Begoña, MD, PhD</au><au>Juan, Miquel, MD</au><au>Serrano, Ariana, MD</au><au>Llurba, Elisa, MD, PhD</au><au>Higueras, Teresa, MD, PhD</au><au>Carreras, Elena, MD, PhD</au><au>Cabero, Luis, MD, PhD</au><aucorp>PECEP-Twins Trial Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2016-02-01</date><risdate>2016</risdate><volume>214</volume><issue>2</issue><spage>145</spage><epage>152</epage><pages>145-152</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><abstract>Background Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. Study Design A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov , number NCT01242410 . Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated. Results Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g ( P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed. Conclusion The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26627728</pmid><doi>10.1016/j.ajog.2015.11.012</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-4001-2017</orcidid></addata></record> |
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| subjects | Adult cervical length Cervical Length Measurement Cervix Uteri - diagnostic imaging Chorioamnionitis - epidemiology Female Fetal Membranes, Premature Rupture - epidemiology Hospitalization - statistics & numerical data Humans Infant, Low Birth Weight Infant, Newborn Length of Stay neonatal morbidity and mortality Obstetrics and Gynecology Pessaries Pregnancy Pregnancy, Twin Premature Birth - prevention & control prematurity preterm birth short cervix Spain Tocolysis - utilization Treatment Outcome twins |
| title | Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins) |
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