Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis
Summary Background Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefi...
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| Veröffentlicht in: | The Lancet (British edition) 2009-06, Vol.373 (9680), p.2034-2040 |
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| creator | Norman, Jane E, Prof Mackenzie, Fiona, MB Owen, Philip, MD Mactier, Helen, MD Hanretty, Kevin, MD Cooper, Sarah, MD Calder, Andrew, Prof Mires, Gary, Prof Danielian, Peter, MD Sturgiss, Stephen, MD MacLennan, Graeme, MSc Tydeman, Graham, MB Thornton, Steven, Prof Martin, Bill, DM Thornton, James G, Prof Neilson, James P, Prof Norrie, John, Prof |
| description | Summary Background Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. Methods In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early ( |
| doi_str_mv | 10.1016/S0140-6736(09)60947-8 |
| format | Article |
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Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. Methods In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. Findings Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24·7% (61/247) in the progesterone group and 19·4% (48/247) in the placebo group (odds ratio [OR] 1·36, 95% CI 0·89–2·09; p=0·16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1·16, 95% CI 0·89–1·51). Interpretation Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. Funding Chief Scientist Office of the Scottish Government Health Directorate.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(09)60947-8</identifier><identifier>PMID: 19523680</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Administration, Intravaginal ; Adolescent ; Adult ; Biological and medical sciences ; Clinical trials ; Delivery, Obstetric - methods ; Delivery, Obstetric - statistics & numerical data ; Double-Blind Method ; Female ; Fetal Death - prevention & control ; Follow-Up Studies ; Gels ; General aspects ; Humans ; Internal Medicine ; Likelihood Functions ; Linear Models ; Logistic Models ; Medical sciences ; Meta-analysis ; Middle Aged ; Miscellaneous ; Mortality ; Obstetrics ; Patient Selection ; Pregnancy ; Pregnancy Outcome - epidemiology ; Pregnancy, High-Risk ; Pregnancy, Multiple - statistics & numerical data ; Premature Birth - epidemiology ; Premature Birth - prevention & control ; Prevention ; Prevention and actions ; Progesterone ; Progesterone - adverse effects ; Progesterone - therapeutic use ; Progestins - adverse effects ; Progestins - therapeutic use ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Studies ; Systematic review ; Treatment Failure ; Twins ; United Kingdom - epidemiology ; Womens health ; Young Adult</subject><ispartof>The Lancet (British edition), 2009-06, Vol.373 (9680), p.2034-2040</ispartof><rights>Elsevier Ltd</rights><rights>2009 Elsevier Ltd</rights><rights>2009 INIST-CNRS</rights><rights>Copyright Elsevier Limited Jun 13-Jun 19, 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c522t-714a26fff8472c326fb471c35e1440176e346c487f78848840f54a58962cf3f13</citedby><cites>FETCH-LOGICAL-c522t-714a26fff8472c326fb471c35e1440176e346c487f78848840f54a58962cf3f13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673609609478$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21556887$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19523680$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Norman, Jane E, Prof</creatorcontrib><creatorcontrib>Mackenzie, Fiona, MB</creatorcontrib><creatorcontrib>Owen, Philip, MD</creatorcontrib><creatorcontrib>Mactier, Helen, MD</creatorcontrib><creatorcontrib>Hanretty, Kevin, MD</creatorcontrib><creatorcontrib>Cooper, Sarah, MD</creatorcontrib><creatorcontrib>Calder, Andrew, Prof</creatorcontrib><creatorcontrib>Mires, Gary, Prof</creatorcontrib><creatorcontrib>Danielian, Peter, MD</creatorcontrib><creatorcontrib>Sturgiss, Stephen, MD</creatorcontrib><creatorcontrib>MacLennan, Graeme, MSc</creatorcontrib><creatorcontrib>Tydeman, Graham, MB</creatorcontrib><creatorcontrib>Thornton, Steven, Prof</creatorcontrib><creatorcontrib>Martin, Bill, DM</creatorcontrib><creatorcontrib>Thornton, James G, Prof</creatorcontrib><creatorcontrib>Neilson, James P, Prof</creatorcontrib><creatorcontrib>Norrie, John, Prof</creatorcontrib><title>Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. Methods In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. Findings Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24·7% (61/247) in the progesterone group and 19·4% (48/247) in the placebo group (odds ratio [OR] 1·36, 95% CI 0·89–2·09; p=0·16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1·16, 95% CI 0·89–1·51). Interpretation Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. Funding Chief Scientist Office of the Scottish Government Health Directorate.</description><subject>Administration, Intravaginal</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Delivery, Obstetric - methods</subject><subject>Delivery, Obstetric - statistics & numerical data</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fetal Death - prevention & control</subject><subject>Follow-Up Studies</subject><subject>Gels</subject><subject>General aspects</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Likelihood Functions</subject><subject>Linear Models</subject><subject>Logistic Models</subject><subject>Medical sciences</subject><subject>Meta-analysis</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Mortality</subject><subject>Obstetrics</subject><subject>Patient Selection</subject><subject>Pregnancy</subject><subject>Pregnancy Outcome - epidemiology</subject><subject>Pregnancy, High-Risk</subject><subject>Pregnancy, Multiple - statistics & numerical data</subject><subject>Premature Birth - epidemiology</subject><subject>Premature Birth - prevention & control</subject><subject>Prevention</subject><subject>Prevention and actions</subject><subject>Progesterone</subject><subject>Progesterone - adverse effects</subject><subject>Progesterone - therapeutic use</subject><subject>Progestins - adverse effects</subject><subject>Progestins - therapeutic use</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Treatment Failure</subject><subject>Twins</subject><subject>United Kingdom - epidemiology</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkW1r3SAUx2VsrLfdPsKGDAYtLJsmRs1ebIyyh0KhF3oHeyfGHFu7RG81acn32Aee94EW9mYg6tHf-Xv8H4ReUfKeEso_XBLKSMFFxY9Jc8JJw0Qhn6AFZYIVNRO_nqLFA3KADlO6IYQwTurn6IA2dVlxSRbozzKGK0gjxOAB2xDxeA14HeEO_OiCx8Fuonw_4NbF8Ro7j8f7POXTK6-9mfHx5epiuTxbnXzEGkftuzC4BN073IWp7aFoe-dztO61gTYUJvgxhr6HDqdx6macM_AAoy601_2cXHqBnlndJ3i5X4_Qz29fV6c_ivOL72enX84LU5flWAjKdMmttZKJ0lR52zJBTVUDZYxQwaFi3DAprJCS5UFszXQtG14aW1laHaE3O911DLdTdkHdhCnmIpKiTZPN4iXPUL2DTAwpRbBqHd2g46woUZtWqG0r1MZnRRq1bYWSOe_1XnxqB-ges_beZ-DtHtDJ6N5m54xLD1xJ65pLKTL3ecdBtuLOQVTJOPAGOhfBjKoL7r-lfPpHweSWuPzob5ghPX5apVKRnchGgzRbBVn9BS29usk</recordid><startdate>20090613</startdate><enddate>20090613</enddate><creator>Norman, Jane E, Prof</creator><creator>Mackenzie, Fiona, MB</creator><creator>Owen, Philip, MD</creator><creator>Mactier, Helen, MD</creator><creator>Hanretty, Kevin, MD</creator><creator>Cooper, Sarah, MD</creator><creator>Calder, Andrew, Prof</creator><creator>Mires, Gary, Prof</creator><creator>Danielian, Peter, MD</creator><creator>Sturgiss, Stephen, MD</creator><creator>MacLennan, Graeme, MSc</creator><creator>Tydeman, Graham, MB</creator><creator>Thornton, Steven, Prof</creator><creator>Martin, Bill, DM</creator><creator>Thornton, James G, Prof</creator><creator>Neilson, James P, Prof</creator><creator>Norrie, John, Prof</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</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></search><sort><creationdate>20090613</creationdate><title>Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis</title><author>Norman, Jane E, Prof ; Mackenzie, Fiona, MB ; Owen, Philip, MD ; Mactier, Helen, MD ; Hanretty, Kevin, MD ; Cooper, Sarah, MD ; Calder, Andrew, Prof ; Mires, Gary, Prof ; Danielian, Peter, MD ; Sturgiss, Stephen, MD ; MacLennan, Graeme, MSc ; Tydeman, Graham, MB ; Thornton, Steven, Prof ; Martin, Bill, DM ; Thornton, James G, Prof ; Neilson, James P, Prof ; Norrie, John, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c522t-714a26fff8472c326fb471c35e1440176e346c487f78848840f54a58962cf3f13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Administration, Intravaginal</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Delivery, Obstetric - methods</topic><topic>Delivery, Obstetric - statistics & numerical data</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fetal Death - prevention & control</topic><topic>Follow-Up Studies</topic><topic>Gels</topic><topic>General aspects</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Likelihood Functions</topic><topic>Linear Models</topic><topic>Logistic Models</topic><topic>Medical sciences</topic><topic>Meta-analysis</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Mortality</topic><topic>Obstetrics</topic><topic>Patient Selection</topic><topic>Pregnancy</topic><topic>Pregnancy Outcome - epidemiology</topic><topic>Pregnancy, High-Risk</topic><topic>Pregnancy, Multiple - statistics & numerical data</topic><topic>Premature Birth - epidemiology</topic><topic>Premature Birth - prevention & control</topic><topic>Prevention</topic><topic>Prevention and actions</topic><topic>Progesterone</topic><topic>Progesterone - adverse effects</topic><topic>Progesterone - therapeutic use</topic><topic>Progestins - adverse effects</topic><topic>Progestins - therapeutic use</topic><topic>Public health. Hygiene</topic><topic>Public health. 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Graham, MB</au><au>Thornton, Steven, Prof</au><au>Martin, Bill, DM</au><au>Thornton, James G, Prof</au><au>Neilson, James P, Prof</au><au>Norrie, John, Prof</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2009-06-13</date><risdate>2009</risdate><volume>373</volume><issue>9680</issue><spage>2034</spage><epage>2040</epage><pages>2034-2040</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. Methods In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. Findings Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24·7% (61/247) in the progesterone group and 19·4% (48/247) in the placebo group (odds ratio [OR] 1·36, 95% CI 0·89–2·09; p=0·16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1·16, 95% CI 0·89–1·51). Interpretation Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. Funding Chief Scientist Office of the Scottish Government Health Directorate.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19523680</pmid><doi>10.1016/S0140-6736(09)60947-8</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2009-06, Vol.373 (9680), p.2034-2040 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_journals_199046626 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Administration, Intravaginal Adolescent Adult Biological and medical sciences Clinical trials Delivery, Obstetric - methods Delivery, Obstetric - statistics & numerical data Double-Blind Method Female Fetal Death - prevention & control Follow-Up Studies Gels General aspects Humans Internal Medicine Likelihood Functions Linear Models Logistic Models Medical sciences Meta-analysis Middle Aged Miscellaneous Mortality Obstetrics Patient Selection Pregnancy Pregnancy Outcome - epidemiology Pregnancy, High-Risk Pregnancy, Multiple - statistics & numerical data Premature Birth - epidemiology Premature Birth - prevention & control Prevention Prevention and actions Progesterone Progesterone - adverse effects Progesterone - therapeutic use Progestins - adverse effects Progestins - therapeutic use Public health. Hygiene Public health. Hygiene-occupational medicine Studies Systematic review Treatment Failure Twins United Kingdom - epidemiology Womens health Young Adult |
| title | Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T10%3A15%3A25IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Progesterone%20for%20the%20prevention%20of%20preterm%20birth%20in%20twin%20pregnancy%20(STOPPIT):%20a%20randomised,%20double-blind,%20placebo-controlled%20study%20and%20meta-analysis&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Norman,%20Jane%20E,%20Prof&rft.date=2009-06-13&rft.volume=373&rft.issue=9680&rft.spage=2034&rft.epage=2040&rft.pages=2034-2040&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(09)60947-8&rft_dat=%3Cproquest_cross%3E1752469471%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=199046626&rft_id=info:pmid/19523680&rft_els_id=1_s2_0_S0140673609609478&rfr_iscdi=true |