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

BMC Pregnancy and Childbirth. 2017;17(1):1-7 DOI 10.1186/s12884-017-1338-0

 

Journal Homepage

Journal Title: BMC Pregnancy and Childbirth

ISSN: 1471-2393 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Gynecology and obstetrics

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS

Laura Visser (Department of Obstetrics and Gynecology, VU University Medical Center)
Marjon A. de Boer (Department of Obstetrics and Gynecology, VU University Medical Center)
Christianne J. M. de Groot (Department of Obstetrics and Gynecology, VU University Medical Center)
Tobias A. J. Nijman (Department of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht)
Marieke A. C. Hemels (Department of Neonatology, Isala Clinic)
Kitty W. M. Bloemenkamp (Department of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht)
Judith E. Bosmans (Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam)
Marjolein Kok (Department of Obstetrics and Gynecology, Academic Medical Center)
Judith O. van Laar (Department of Obstetrics and Gynecology, Maxima Medical Center in Veldhoven)
Marieke Sueters (Department of Obstetrics and Gynecology, Leiden University Medical Center)
Hubertina Scheepers (Department of Obstetrics and Gynecology, Maastricht University Medical Center)
Joris van Drongelen (Department of Obstetrics and Gynecology, Radboud University Medical Center)
Maureen T. M. Franssen (Department of Obstetrics and Gynecology, University Medical Center Groningen)
J. Marko Sikkema (Department of Obstetrics and Gynecology, Hospital Group Twente)
Hans J. J. Duvekot (Department of Obstetrics and Gynecology, Erasmus Medical Center)
Mireille N. Bekker (Department of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht)
Joris A. M. van der Post (Department of Obstetrics and Gynecology, Academic Medical Center)
Christiana Naaktgeboren (Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht)
Ben W. J. Mol (Department of Obstetrics and Gynecology, Robinson Research Institute, University of Adelaide)
Martijn A. Oudijk (Department of Obstetrics and Gynecology, Academic Medical Center)

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 21 weeks

 

Abstract | Full Text

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 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.