Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial
Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating conc...
Gespeichert in:
| Veröffentlicht in: | The Lancet (British edition) 2019-05, Vol.393 (10183), p.1807-1818 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1818 |
|---|---|
| container_issue | 10183 |
| container_start_page | 1807 |
| container_title | The Lancet (British edition) |
| container_volume | 393 |
| creator | Duhig, Kate E Myers, Jenny Seed, Paul T Sparkes, Jenie Lowe, Jessica Hunter, Rachael M Shennan, Andrew H Chappell, Lucy C Bahl, Rachna Bambridge, Gabrielle Barnfield, Sonia Ficquet, Jo Gill, Carolyn Girling, Joanna Harding, Kate Khalil, Asma Sharp, Andrew Simpson, Nigel Tuffnell, Derek |
| description | Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes.
We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031.
Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspe |
| doi_str_mv | 10.1016/S0140-6736(18)33212-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6497988</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0140673618332124</els_id><sourcerecordid>2204691961</sourcerecordid><originalsourceid>FETCH-LOGICAL-c495t-b72afd05cf284dc471da17bf4d170d699718e24f85bf9f4e521be8687b5e06333</originalsourceid><addsrcrecordid>eNqFkV1rFDEUhoModlv9CUrAmxY6msxkJokXihS_oKCggnchk5zZpmQm0yTTxZ_ivzW7Wxf1xqt8PefNec-L0BNKnlNCuxdfCGWk6njTnVJx1jQ1rSt2D60o46xqGf9-H60OyBE6TumaEMI60j5ERw2RTNSCrdDPz14bmLL2eB3DJl_hQZscIs6QspvWOAesU4KU8CaMMOGNK0xa0gwmg8VzhAqM1-OcnH6JNR4Xn91WMcJ5edXrUZfzOU4Z5hlstQG7Bmz8Ui5iFfVkw-hSUTKh1ATvyzZHp_0j9GDQPsHju_UEfXv39uvFh-ry0_uPF28uK8Nkm6ue13qwpDVD8WMN49RqyvuBWcqJ7aTkVEDNBtH2gxwYtDXtQXSC9y2QrmmaE_Rqrzsv_Qh217r2ao5u1PGHCtqpv18md6XW4VZ1THIpRBE4vROI4WYpY1PFkAHv9QRhSaquy9gllR0t6LN_0OuwxKnYKxQVsm72VLunTAwpRRgOzVCituGrXfhqm6yiQu3CV6zUPf3TyaHqd9oFeL0HoMzz1kFUyTiYDFgXS5zKBvefL34BdoDDew</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2218923961</pqid></control><display><type>article</type><title>Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Duhig, Kate E ; Myers, Jenny ; Seed, Paul T ; Sparkes, Jenie ; Lowe, Jessica ; Hunter, Rachael M ; Shennan, Andrew H ; Chappell, Lucy C ; Bahl, Rachna ; Bambridge, Gabrielle ; Barnfield, Sonia ; Ficquet, Jo ; Gill, Carolyn ; Girling, Joanna ; Harding, Kate ; Khalil, Asma ; Sharp, Andrew ; Simpson, Nigel ; Tuffnell, Derek</creator><creatorcontrib>Duhig, Kate E ; Myers, Jenny ; Seed, Paul T ; Sparkes, Jenie ; Lowe, Jessica ; Hunter, Rachael M ; Shennan, Andrew H ; Chappell, Lucy C ; Bahl, Rachna ; Bambridge, Gabrielle ; Barnfield, Sonia ; Ficquet, Jo ; Gill, Carolyn ; Girling, Joanna ; Harding, Kate ; Khalil, Asma ; Sharp, Andrew ; Simpson, Nigel ; Tuffnell, Derek ; PARROT trial group</creatorcontrib><description>Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes.
We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031.
Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the concealed testing group withdrew consent to follow-up data collection, so 446 (>99%) women in this group were included in the analyses. The median time to pre-eclampsia diagnosis was 4·1 days with concealed testing versus 1·9 days with revealed testing (time ratio 0·36, 95% CI 0·15–0·87; p=0·027). Maternal severe adverse outcomes were reported in 24 (5%) of 447 women in the concealed testing group versus 22 (4%) of 573 women in the revealed testing group (adjusted odds ratio 0·32, 95% CI 0·11–0·96; p=0·043), but there was no evidence of a difference in perinatal adverse outcomes (15% vs 14%, 1·45, 0·73–2·90) or gestation at delivery (36·6 weeks vs 36·8 weeks; mean difference −0·52, 95% CI −0·63 to 0·73).
We found that the availability of PlGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PlGF was implemented, we found a lower incidence of maternal adverse outcomes, consistent with adoption of targeted, enhanced surveillance, as recommended in the clinical management algorithm for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study.
National Institute for Health Research.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(18)33212-4</identifier><identifier>PMID: 30948284</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Algorithms ; Angiogenesis ; Blood ; Clusters ; Data collection ; Diagnosis ; Diagnostic systems ; Evidence-based medicine ; Female ; Fetal Growth Retardation - diagnosis ; Fetuses ; Gestation ; Gestational Age ; Growth factors ; Headache ; Humans ; Hypertension ; Hypertension - complications ; Hypertension - diagnosis ; Hypertension - epidemiology ; Infant, Newborn ; Management ; Outcome Assessment, Health Care ; Pain ; Perinatal Death ; Placenta ; Placenta Growth Factor - blood ; Pre-eclampsia ; Pre-Eclampsia - diagnosis ; Pre-Eclampsia - epidemiology ; Pre-Eclampsia - metabolism ; Pre-Eclampsia - physiopathology ; Preeclampsia ; Pregnancy ; Pregnancy Complications - epidemiology ; Pregnancy Outcome - epidemiology ; Proteinuria ; Proteinuria - complications ; Proteinuria - diagnosis ; Proteinuria - epidemiology ; Randomization ; Renal function ; Thrombocytopenia ; Wedges ; Womens health</subject><ispartof>The Lancet (British edition), 2019-05, Vol.393 (10183), p.1807-1818</ispartof><rights>2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license</rights><rights>Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2019. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.</rights><rights>2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c495t-b72afd05cf284dc471da17bf4d170d699718e24f85bf9f4e521be8687b5e06333</citedby><cites>FETCH-LOGICAL-c495t-b72afd05cf284dc471da17bf4d170d699718e24f85bf9f4e521be8687b5e06333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673618332124$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30948284$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Duhig, Kate E</creatorcontrib><creatorcontrib>Myers, Jenny</creatorcontrib><creatorcontrib>Seed, Paul T</creatorcontrib><creatorcontrib>Sparkes, Jenie</creatorcontrib><creatorcontrib>Lowe, Jessica</creatorcontrib><creatorcontrib>Hunter, Rachael M</creatorcontrib><creatorcontrib>Shennan, Andrew H</creatorcontrib><creatorcontrib>Chappell, Lucy C</creatorcontrib><creatorcontrib>Bahl, Rachna</creatorcontrib><creatorcontrib>Bambridge, Gabrielle</creatorcontrib><creatorcontrib>Barnfield, Sonia</creatorcontrib><creatorcontrib>Ficquet, Jo</creatorcontrib><creatorcontrib>Gill, Carolyn</creatorcontrib><creatorcontrib>Girling, Joanna</creatorcontrib><creatorcontrib>Harding, Kate</creatorcontrib><creatorcontrib>Khalil, Asma</creatorcontrib><creatorcontrib>Sharp, Andrew</creatorcontrib><creatorcontrib>Simpson, Nigel</creatorcontrib><creatorcontrib>Tuffnell, Derek</creatorcontrib><creatorcontrib>PARROT trial group</creatorcontrib><title>Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes.
We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031.
Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the concealed testing group withdrew consent to follow-up data collection, so 446 (>99%) women in this group were included in the analyses. The median time to pre-eclampsia diagnosis was 4·1 days with concealed testing versus 1·9 days with revealed testing (time ratio 0·36, 95% CI 0·15–0·87; p=0·027). Maternal severe adverse outcomes were reported in 24 (5%) of 447 women in the concealed testing group versus 22 (4%) of 573 women in the revealed testing group (adjusted odds ratio 0·32, 95% CI 0·11–0·96; p=0·043), but there was no evidence of a difference in perinatal adverse outcomes (15% vs 14%, 1·45, 0·73–2·90) or gestation at delivery (36·6 weeks vs 36·8 weeks; mean difference −0·52, 95% CI −0·63 to 0·73).
We found that the availability of PlGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PlGF was implemented, we found a lower incidence of maternal adverse outcomes, consistent with adoption of targeted, enhanced surveillance, as recommended in the clinical management algorithm for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study.
National Institute for Health Research.</description><subject>Adult</subject><subject>Algorithms</subject><subject>Angiogenesis</subject><subject>Blood</subject><subject>Clusters</subject><subject>Data collection</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Fetal Growth Retardation - diagnosis</subject><subject>Fetuses</subject><subject>Gestation</subject><subject>Gestational Age</subject><subject>Growth factors</subject><subject>Headache</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypertension - complications</subject><subject>Hypertension - diagnosis</subject><subject>Hypertension - epidemiology</subject><subject>Infant, Newborn</subject><subject>Management</subject><subject>Outcome Assessment, Health Care</subject><subject>Pain</subject><subject>Perinatal Death</subject><subject>Placenta</subject><subject>Placenta Growth Factor - blood</subject><subject>Pre-eclampsia</subject><subject>Pre-Eclampsia - diagnosis</subject><subject>Pre-Eclampsia - epidemiology</subject><subject>Pre-Eclampsia - metabolism</subject><subject>Pre-Eclampsia - physiopathology</subject><subject>Preeclampsia</subject><subject>Pregnancy</subject><subject>Pregnancy Complications - epidemiology</subject><subject>Pregnancy Outcome - epidemiology</subject><subject>Proteinuria</subject><subject>Proteinuria - complications</subject><subject>Proteinuria - diagnosis</subject><subject>Proteinuria - epidemiology</subject><subject>Randomization</subject><subject>Renal function</subject><subject>Thrombocytopenia</subject><subject>Wedges</subject><subject>Womens health</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkV1rFDEUhoModlv9CUrAmxY6msxkJokXihS_oKCggnchk5zZpmQm0yTTxZ_ivzW7Wxf1xqt8PefNec-L0BNKnlNCuxdfCGWk6njTnVJx1jQ1rSt2D60o46xqGf9-H60OyBE6TumaEMI60j5ERw2RTNSCrdDPz14bmLL2eB3DJl_hQZscIs6QspvWOAesU4KU8CaMMOGNK0xa0gwmg8VzhAqM1-OcnH6JNR4Xn91WMcJ5edXrUZfzOU4Z5hlstQG7Bmz8Ui5iFfVkw-hSUTKh1ATvyzZHp_0j9GDQPsHju_UEfXv39uvFh-ry0_uPF28uK8Nkm6ue13qwpDVD8WMN49RqyvuBWcqJ7aTkVEDNBtH2gxwYtDXtQXSC9y2QrmmaE_Rqrzsv_Qh217r2ao5u1PGHCtqpv18md6XW4VZ1THIpRBE4vROI4WYpY1PFkAHv9QRhSaquy9gllR0t6LN_0OuwxKnYKxQVsm72VLunTAwpRRgOzVCituGrXfhqm6yiQu3CV6zUPf3TyaHqd9oFeL0HoMzz1kFUyTiYDFgXS5zKBvefL34BdoDDew</recordid><startdate>20190504</startdate><enddate>20190504</enddate><creator>Duhig, Kate E</creator><creator>Myers, Jenny</creator><creator>Seed, Paul T</creator><creator>Sparkes, Jenie</creator><creator>Lowe, Jessica</creator><creator>Hunter, Rachael M</creator><creator>Shennan, Andrew H</creator><creator>Chappell, Lucy C</creator><creator>Bahl, Rachna</creator><creator>Bambridge, Gabrielle</creator><creator>Barnfield, Sonia</creator><creator>Ficquet, Jo</creator><creator>Gill, Carolyn</creator><creator>Girling, Joanna</creator><creator>Harding, Kate</creator><creator>Khalil, Asma</creator><creator>Sharp, Andrew</creator><creator>Simpson, Nigel</creator><creator>Tuffnell, Derek</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><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>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190504</creationdate><title>Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial</title><author>Duhig, Kate E ; Myers, Jenny ; Seed, Paul T ; Sparkes, Jenie ; Lowe, Jessica ; Hunter, Rachael M ; Shennan, Andrew H ; Chappell, Lucy C ; Bahl, Rachna ; Bambridge, Gabrielle ; Barnfield, Sonia ; Ficquet, Jo ; Gill, Carolyn ; Girling, Joanna ; Harding, Kate ; Khalil, Asma ; Sharp, Andrew ; Simpson, Nigel ; Tuffnell, Derek</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c495t-b72afd05cf284dc471da17bf4d170d699718e24f85bf9f4e521be8687b5e06333</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Algorithms</topic><topic>Angiogenesis</topic><topic>Blood</topic><topic>Clusters</topic><topic>Data collection</topic><topic>Diagnosis</topic><topic>Diagnostic systems</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Fetal Growth Retardation - diagnosis</topic><topic>Fetuses</topic><topic>Gestation</topic><topic>Gestational Age</topic><topic>Growth factors</topic><topic>Headache</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hypertension - complications</topic><topic>Hypertension - diagnosis</topic><topic>Hypertension - epidemiology</topic><topic>Infant, Newborn</topic><topic>Management</topic><topic>Outcome Assessment, Health Care</topic><topic>Pain</topic><topic>Perinatal Death</topic><topic>Placenta</topic><topic>Placenta Growth Factor - blood</topic><topic>Pre-eclampsia</topic><topic>Pre-Eclampsia - diagnosis</topic><topic>Pre-Eclampsia - epidemiology</topic><topic>Pre-Eclampsia - metabolism</topic><topic>Pre-Eclampsia - physiopathology</topic><topic>Preeclampsia</topic><topic>Pregnancy</topic><topic>Pregnancy Complications - epidemiology</topic><topic>Pregnancy Outcome - epidemiology</topic><topic>Proteinuria</topic><topic>Proteinuria - complications</topic><topic>Proteinuria - diagnosis</topic><topic>Proteinuria - epidemiology</topic><topic>Randomization</topic><topic>Renal function</topic><topic>Thrombocytopenia</topic><topic>Wedges</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Duhig, Kate E</creatorcontrib><creatorcontrib>Myers, Jenny</creatorcontrib><creatorcontrib>Seed, Paul T</creatorcontrib><creatorcontrib>Sparkes, Jenie</creatorcontrib><creatorcontrib>Lowe, Jessica</creatorcontrib><creatorcontrib>Hunter, Rachael M</creatorcontrib><creatorcontrib>Shennan, Andrew H</creatorcontrib><creatorcontrib>Chappell, Lucy C</creatorcontrib><creatorcontrib>Bahl, Rachna</creatorcontrib><creatorcontrib>Bambridge, Gabrielle</creatorcontrib><creatorcontrib>Barnfield, Sonia</creatorcontrib><creatorcontrib>Ficquet, Jo</creatorcontrib><creatorcontrib>Gill, Carolyn</creatorcontrib><creatorcontrib>Girling, Joanna</creatorcontrib><creatorcontrib>Harding, Kate</creatorcontrib><creatorcontrib>Khalil, Asma</creatorcontrib><creatorcontrib>Sharp, Andrew</creatorcontrib><creatorcontrib>Simpson, Nigel</creatorcontrib><creatorcontrib>Tuffnell, Derek</creatorcontrib><creatorcontrib>PARROT trial group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News & ABI/Inform Professional</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Duhig, Kate E</au><au>Myers, Jenny</au><au>Seed, Paul T</au><au>Sparkes, Jenie</au><au>Lowe, Jessica</au><au>Hunter, Rachael M</au><au>Shennan, Andrew H</au><au>Chappell, Lucy C</au><au>Bahl, Rachna</au><au>Bambridge, Gabrielle</au><au>Barnfield, Sonia</au><au>Ficquet, Jo</au><au>Gill, Carolyn</au><au>Girling, Joanna</au><au>Harding, Kate</au><au>Khalil, Asma</au><au>Sharp, Andrew</au><au>Simpson, Nigel</au><au>Tuffnell, Derek</au><aucorp>PARROT trial group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2019-05-04</date><risdate>2019</risdate><volume>393</volume><issue>10183</issue><spage>1807</spage><epage>1818</epage><pages>1807-1818</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes.
We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031.
Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the concealed testing group withdrew consent to follow-up data collection, so 446 (>99%) women in this group were included in the analyses. The median time to pre-eclampsia diagnosis was 4·1 days with concealed testing versus 1·9 days with revealed testing (time ratio 0·36, 95% CI 0·15–0·87; p=0·027). Maternal severe adverse outcomes were reported in 24 (5%) of 447 women in the concealed testing group versus 22 (4%) of 573 women in the revealed testing group (adjusted odds ratio 0·32, 95% CI 0·11–0·96; p=0·043), but there was no evidence of a difference in perinatal adverse outcomes (15% vs 14%, 1·45, 0·73–2·90) or gestation at delivery (36·6 weeks vs 36·8 weeks; mean difference −0·52, 95% CI −0·63 to 0·73).
We found that the availability of PlGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PlGF was implemented, we found a lower incidence of maternal adverse outcomes, consistent with adoption of targeted, enhanced surveillance, as recommended in the clinical management algorithm for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study.
National Institute for Health Research.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30948284</pmid><doi>10.1016/S0140-6736(18)33212-4</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2019-05, Vol.393 (10183), p.1807-1818 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6497988 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Algorithms Angiogenesis Blood Clusters Data collection Diagnosis Diagnostic systems Evidence-based medicine Female Fetal Growth Retardation - diagnosis Fetuses Gestation Gestational Age Growth factors Headache Humans Hypertension Hypertension - complications Hypertension - diagnosis Hypertension - epidemiology Infant, Newborn Management Outcome Assessment, Health Care Pain Perinatal Death Placenta Placenta Growth Factor - blood Pre-eclampsia Pre-Eclampsia - diagnosis Pre-Eclampsia - epidemiology Pre-Eclampsia - metabolism Pre-Eclampsia - physiopathology Preeclampsia Pregnancy Pregnancy Complications - epidemiology Pregnancy Outcome - epidemiology Proteinuria Proteinuria - complications Proteinuria - diagnosis Proteinuria - epidemiology Randomization Renal function Thrombocytopenia Wedges Womens health |
| title | Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-06T16%3A23%3A14IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Placental%20growth%20factor%20testing%20to%20assess%20women%20with%20suspected%20pre-eclampsia:%20a%20multicentre,%20pragmatic,%20stepped-wedge%20cluster-randomised%20controlled%20trial&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Duhig,%20Kate%20E&rft.aucorp=PARROT%20trial%20group&rft.date=2019-05-04&rft.volume=393&rft.issue=10183&rft.spage=1807&rft.epage=1818&rft.pages=1807-1818&rft.issn=0140-6736&rft.eissn=1474-547X&rft_id=info:doi/10.1016/S0140-6736(18)33212-4&rft_dat=%3Cproquest_pubme%3E2204691961%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2218923961&rft_id=info:pmid/30948284&rft_els_id=S0140673618332124&rfr_iscdi=true |