Low dose aspirin in the prevention of recurrent spontaneous preterm labour – the APRIL study: a multicenter randomized placebo controlled trial

BMC Pregnancy and Childbirth

Study Protocol

Judith E. Bosmans¹  Marieke A. C. Hemels²  Joris A. M. van der Post³  Marjolein Kok³  Martijn A. Oudijk³  Tobias A. J. Nijman⁴  Mireille N. Bekker⁴  Kitty W. M. Bloemenkamp⁴  Hans J. J. Duvekot⁵  J. Marko Sikkema⁶  Marieke Sueters⁷  Hubertina Scheepers⁸  Judith O. van Laar⁹  Joris van Drongelen^1,10  Ben W. J. Mol^1,11  Maureen T. M. Franssen^1,12  Marjon A. de Boer^1,13  Christianne J. M. de Groot^1,13  Laura Visser^1,13  Christiana Naaktgeboren^1,14 

[1] Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands;Department of Neonatology, Isala Clinic, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands;Department of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands;Department of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands;Department of Obstetrics and Gynecology, Erasmus Medical Center, ‘s- Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands;Department of Obstetrics and Gynecology, Hospital Group Twente, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands;Department of Obstetrics and Gynecology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands;Department of Obstetrics and Gynecology, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands;Department of Obstetrics and Gynecology, Maxima Medical Center in Veldhoven, De Run 4600, 5504 DB, Veldhoven, The Netherlands;Department of Obstetrics and Gynecology, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, The Netherlands;Department of Obstetrics and Gynecology, Robinson Research Institute, University of Adelaide, 72 King William St, SA 5006, North Adelaide, Australia;Department of Obstetrics and Gynecology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands;Department of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands;

关键词: Pregnancy;    ‘Spontaneous recurrent preterm birth’;    SPTB;    Preterm birth;    Preterm labour;    PTB;    Prevention;    Reduction;    Aspirin;    Acetylsalicylic acid;    ASA;   

DOI  :  10.1186/s12884-017-1338-0

 received in 2017-02-14, accepted in 2017-05-19,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPreterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.Methods/designWomen with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22–37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.DiscussionThis trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.Trial registrationClinical trial registration number of the Dutch Trial Register: NTR 5675. EudraCT-registration number: 2015-003220-31.

【 授权许可】

CC BY   
© The Author(s). 2017