Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial)
<p>Abstract</p> <p>Background</p> <p>Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This al...
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BMC
2009-09-01
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| Series: | BMC Pregnancy and Childbirth |
| Online Access: | http://www.biomedcentral.com/1471-2393/9/42 |
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| author | Scherjon Sicco A van der Post Joris AM Porath Martina M Papatsonis Dimitri NM van Pampus Mariëlle G Opmeer Brent C Merién Ashley Kwee Anneke Kok Joke H van Eyck Jim Duvekot Hans JJ Derks Jan B Cornette Jerome Bolte Annemiek Bloemenkamp Kitty WM Scheepers Liesbeth HCJ Roos Carolien Sollie Krystyne Spaanderman Marc EA Vijgen Sylvia MC Willekes Christine Mol Ben Lotgering Fred K |
| author_facet | Scherjon Sicco A van der Post Joris AM Porath Martina M Papatsonis Dimitri NM van Pampus Mariëlle G Opmeer Brent C Merién Ashley Kwee Anneke Kok Joke H van Eyck Jim Duvekot Hans JJ Derks Jan B Cornette Jerome Bolte Annemiek Bloemenkamp Kitty WM Scheepers Liesbeth HCJ Roos Carolien Sollie Krystyne Spaanderman Marc EA Vijgen Sylvia MC Willekes Christine Mol Ben Lotgering Fred K |
| author_sort | Scherjon Sicco A |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours.</p> <p>Methods/Design</p> <p>The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26<sup>+0 </sup>and 32<sup>+2 </sup>weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.</p> <p>Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05).</p> <p>Discussion</p> <p>This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks.</p> <p>Trial Registration</p> <p>Clinical trial registration: <url>http://www.trialregister.nl</url>, NTR 1336, date of registration: June 3<sup>rd </sup>2008.</p> |
| first_indexed | 2024-12-13T23:22:35Z |
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| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-13T23:22:35Z |
| publishDate | 2009-09-01 |
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| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-383e2531789b4172a864ef24b22f5b712022-12-21T23:27:39ZengBMCBMC Pregnancy and Childbirth1471-23932009-09-01914210.1186/1471-2393-9-42Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial)Scherjon Sicco Avan der Post Joris AMPorath Martina MPapatsonis Dimitri NMvan Pampus Mariëlle GOpmeer Brent CMerién AshleyKwee AnnekeKok Joke Hvan Eyck JimDuvekot Hans JJDerks Jan BCornette JeromeBolte AnnemiekBloemenkamp Kitty WMScheepers Liesbeth HCJRoos CarolienSollie KrystyneSpaanderman Marc EAVijgen Sylvia MCWillekes ChristineMol BenLotgering Fred K<p>Abstract</p> <p>Background</p> <p>Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours.</p> <p>Methods/Design</p> <p>The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26<sup>+0 </sup>and 32<sup>+2 </sup>weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.</p> <p>Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05).</p> <p>Discussion</p> <p>This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks.</p> <p>Trial Registration</p> <p>Clinical trial registration: <url>http://www.trialregister.nl</url>, NTR 1336, date of registration: June 3<sup>rd </sup>2008.</p>http://www.biomedcentral.com/1471-2393/9/42 |
| spellingShingle | Scherjon Sicco A van der Post Joris AM Porath Martina M Papatsonis Dimitri NM van Pampus Mariëlle G Opmeer Brent C Merién Ashley Kwee Anneke Kok Joke H van Eyck Jim Duvekot Hans JJ Derks Jan B Cornette Jerome Bolte Annemiek Bloemenkamp Kitty WM Scheepers Liesbeth HCJ Roos Carolien Sollie Krystyne Spaanderman Marc EA Vijgen Sylvia MC Willekes Christine Mol Ben Lotgering Fred K Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) BMC Pregnancy and Childbirth |
| title | Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) |
| title_full | Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) |
| title_fullStr | Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) |
| title_full_unstemmed | Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) |
| title_short | Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial) |
| title_sort | assessment of perinatal outcome after sustained tocolysis in early labour apostel ii trial |
| url | http://www.biomedcentral.com/1471-2393/9/42 |
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