Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial

The Lancet - Tập 387 - Trang 2117-2124 - 2016
Elvira O G van Vliet1, Tobias A J Nijman1, Ewoud Schuit2,3, Karst Y Heida1, Brent C Opmeer4, Marjolein Kok5, Wilfried Gyselaers6,7, Martina M Porath8, Mallory Woiski9, Caroline J Bax10, Kitty W M Bloemenkamp1,11, Hubertina C J Scheepers12, Yves Jacquemyn13, Erik van Beek14, Johannes J Duvekot15, Maureen T M Franssen16, Dimitri N Papatsonis17, Joke H Kok18, Joris A M van der Post5, Arie Franx1
1Department of Obstetrics, Wilhelmina Hospital Birth Centre, Division Woman and Baby, University Medical Centre Utrecht, Utrecht, Netherlands
2Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, Netherlands
3Stanford Prevention Research Center, Stanford University, Stanford, CA, USA
4Clinical Research Unit, Academic Medical Centre, Amsterdam, Netherlands
5Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, Netherlands
6Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium
7Department of Physiology, Hasselt University, Diepenbeek, Belgium
8Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, Netherlands
9Department of Obstetrics and Gynaecology, University Medical Centre Nijmegen, Nijmegen, Netherlands
10Department of Obstetrics and Gynaecology, Vrije University Medical Centre, Amsterdam, Netherlands
11Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands
12Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, Netherlands
13Department of Gynecology and Obstetrics, Antwerp University Hospital, Antwerp, Belgium
14Department of Obstetrics and Gynaecology, St Antonius Hospital, Nieuwegein, Netherlands
15Department of Obstetrics and Gynecology, Erasmus University Medical Centre, Rotterdam, Netherlands
16Department of Obstetrics, University Medical Centre, University of Groningen, Groningen, Netherlands
17Department of Obstetrics and Gynecology, Amphia Hospital, Breda, Netherlands
18Department of Neonatology, Academic Medical Centre, Amsterdam, Netherlands

Tài liệu tham khảo

Blencowe, 2013, Born too soon: the global epidemiology of 15 million preterm births, Reprod Health, 10, S2, 10.1186/1742-4755-10-S1-S2 Treyvaud, 2014, Very preterm birth influences parental mental health and family outcomes seven years after birth, J Pediatr, 164, 515, 10.1016/j.jpeds.2013.11.001 Bolisetty, 2006, Preterm outcome table (POT): a simple tool to aid counselling parents of very preterm infants, Aust N Z J Obstet Gynaecol, 46, 189, 10.1111/j.1479-828X.2006.00564.x Ananth, 2006, Epidemiology of preterm birth and its clinical subtypes, J Matern Fetal Neonatal Med, 19, 773, 10.1080/14767050600965882 Goldenberg, 2008, Epidemiology and causes of preterm birth, Lancet, 371, 75, 10.1016/S0140-6736(08)60074-4 Keirse, 2003, The history of tocolysis, BJOG, 110, 94, 10.1046/j.1471-0528.2003.00051.x Hehiri, 2012, Early and late preterm delivery rates—a comparison of differing tocolytic policies in a single urban population, J Matern Fetal Neonatal Med, 25, 2234, 10.3109/14767058.2012.684171 Haas, 2009, Tocolytic therapy: a meta-analysis and decision analysis, Obstet Gynecol, 113, 585, 10.1097/AOG.0b013e318199924a Haas, 2012, Tocolytic therapy for preterm delivery: systematic review and network meta-analysis, BMJ, 345, e6226, 10.1136/bmj.e6226 Berkman, 2003, Tocolytic treatment for the management of preterm labour: A review of the evidence, Am J Obstet Gynecol, 188, 1648, 10.1067/mob.2003.356 Reinebrant, 2015, Cyclo-oxygenase (COX) inhibitors for treating preterm labour, Cochrane Database Syst Rev, 6 Hammers, 2015, Antenatal exposure to indomethacin increases the risk of severe intraventricular hemorrhage, necrotizing enterocolitis, and periventricular leukomalacia: a systematic review with metaanalysis, Am J Obstet Gynecol, 212, 505, 10.1016/j.ajog.2014.10.1091 van Vliet, 2014, Preterm labour: current pharmacotherapy options for tocolysis, Expert Opin Pharmacother, 15, 787, 10.1517/14656566.2014.889684 Flenady, 2014, Calcium channel blockers for inhibiting preterm labour and birth, Cochrane Database Syst Rev, 6 Flenady, 2014, Oxytocin receptor antagonists for inhibiting preterm labour, Cochrane Database Syst Rev, 6 Kashanian, 2005, Atosiban and nifedipin for the treatment of preterm labour, Int J Gynaecol Obstet, 91, 10, 10.1016/j.ijgo.2005.06.005 Al-Omari, 2006, Atosiban and nifedipine in acute tocolysis: a comparative study, Eur J Obstet Gynecol Reprod Biol, 128, 129, 10.1016/j.ejogrb.2005.12.010 Salim, 2012, Nifedipine compared with atosiban for treating preterm labour: a randomised controlled trial, Obstet Gynecol, 120, 1323, 10.1097/AOG.0b013e3182755dff van Vliet, 2014, Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial), BMC Pregnancy Childbirth, 14, 93, 10.1186/1471-2393-14-93 Jobe, 2001, Bronchopulmonary dysplasia, Am J Respir Crit Care Med, 163, 1723, 10.1164/ajrccm.163.7.2011060 de Vries, 1992, The spectrum of leukomalacia using cranial ultrasound, Behav Brain Res, 49, 1, 10.1016/S0166-4328(05)80189-5 Ment, 2002, Practice parameter: neuroimaging of the neonate: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society, Neurology, 58, 1726, 10.1212/WNL.58.12.1726 Bell, 1978, Neonatal necrotizing enterocolitis, Ann Surg, 187, 1, 10.1097/00000658-197801000-00001 Meyboom, 1997, Causal or casual? The role of causality assessment in pharmacovigilance, Drug Saf, 17, 374, 10.2165/00002018-199717060-00004 Gates, 2004, How should randomised trials including multiple pregnancies be analysed?, BJOG, 111, 213, 10.1111/j.1471-0528.2004.00059.x Schoenfeld, 1982, Residuals for the proportional hazards regression model, Biometrika, 69, 239, 10.1093/biomet/69.1.239 Furuhashi, 1991, Effects of nifedipine on normotensive rat placental blood flow, placental weight and fetal weight, Gynecol Obstet Invest, 32, 1, 10.1159/000292979 Harake, 1987, Nifedipine: effects on fetal and maternal hemodynamics in pregnant sheep, Am J Obstet Gynecol, 157, 1003, 10.1016/S0002-9378(87)80104-7 Holbrook, 1987, Cardiovascular and tocolytic effects of nicardipine HCl in the pregnant rabbit: comparison with ritodrine HCl, Obstet Gynecol, 69, 83 Blea, 1997, Effect of nifedipine on fetal and maternal hemodynamics and blood gases in the pregnant ewe, Am J Obstet Gynecol, 176, 922, 10.1016/S0002-9378(97)70622-7 Mari, 1989, Doppler assessment of the fetal and uteroplacental circulation during nifedipine therapy for preterm labour, Am J Obstet Gynecol, 161, 1514, 10.1016/0002-9378(89)90915-0 Pirhonen, 1990, Single dose of nifedipine in normotensive pregnancy: nifedipine concentrations, hemodynamic responses, and uterine and fetal flow velocity waveforms, Obstet Gynecol, 76, 807, 10.1097/00006250-199011000-00016 Guclu, 2004, The short-term effect of nifedipine tocolysis on placental, fetal cerebral and atrioventricular Doppler waveforms, Ultrasound Obstet Gynecol, 24, 761, 10.1002/uog.1770 de Heus, 2009, The effects of the tocolytics atosiban and nifedipine on fetal movements, heart rate and blood flow, J Matern Fetal Neonatal Med, 22, 485, 10.1080/14767050802702349 van Veen, 2005, Severe hypotension and fetal death due to tocolysis with nifedipine, BJOG, 112, 509, 10.1111/j.1471-0528.2004.00480.x de Heus, 2009, Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study, BMJ, 338, b744, 10.1136/bmj.b744 Khan, 2010, Safety concerns for the use of calcium channel blockers in pregnancy for the treatment of spontaneous preterm labour and hypertension: a systematic review and meta-regression analysis, J Matern Fetal Neonatal Med, 23, 1030, 10.3109/14767050903572182 2012, American College of Obstetricians and Gynecologist; Committee on Practice Bulletins, Obstet Gynecol, 119, 1308 2011 Simhan, 2007, Prevention of preterm delivery, N Engl J Med, 357, 477, 10.1056/NEJMra050435 Vogel, 2015, New WHO recommendations to improve the outcomes of preterm birth, Lancet Glob Health, 3, e589, 10.1016/S2214-109X(15)00183-7 Alfirevic, 2012, Tocolytics: do they actually work?, BMJ, 345, e6531, 10.1136/bmj.e6531