Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: A multicenter randomized placebo controlled trial
Visser, Laura; de Boer, Marjon A.; de Groot, Christianne J.M.; Nijman, Tobias A.J.; Hemels, Marieke A.C.; Bloemenkamp, Kitty W.M.; Bosmans, Judith E.; Kok, Marjolein; van Laar, Judith O.; Sueters, Marieke; Scheepers, Hubertina; van Drongelen, Joris; Franssen, Maureen T.M.; Sikkema, J. Marko; Duvekot, Hans J.J.; Bekker, Mireille N.; van der Post, Joris A.M.; Naaktgeboren, Christiana; Mol, Ben W.J.; Oudijk, Martijn A.
(2017) BMC Pregnancy and Childbirth [E], volume 17, issue 1
(Article)
Abstract
Background: Preterm 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
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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/design: Women 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. Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. Trial registration: Clinical trial registration number of the Dutch Trial Register: NTR 5675. EudraCT-registration number: 2015-003220-31.
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Keywords: 'Spontaneous recurrent preterm birth', Acetylsalicylic acid, ASA, Aspirin, Pregnancy, Preterm birth, Preterm labour, Prevention, PTB, Reduction, SPTB, Obstetrics and Gynaecology
ISSN: 1471-2393
Publisher: BioMed Central
Note: Funding Information: This trial is funded by ZonMw grant (The Netherlands organization for health research and development) grant-number: 80-83600-98-40102. Publisher Copyright: © 2017 The Author(s).
(Peer reviewed)