Evidence map›Paper›PMID 28705190›Full record

Trial reportBMC pregnancy and childbirth2017

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

Laura Visser, Marjon A de Boer, Christianne J M de Groot, Tobias A J Nijman, Marieke A C Hemels, Kitty W M Bloemenkamp, Judith E Bosmans, Marjolein Kok, Judith O van Laar, Marieke Sueters and 10 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Antiplatelet agents for preventing pre-eclampsia and its complications.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Cost-effectiveness of a randomized controlled trial comparing low-dose aspirin to placebo for the prevention of recurrent preterm birth.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Trial
  3. Evaluation of the Effect of Low-dose Aspirin on the Prevention of Preterm Delivery in Women with a History of Spontaneous Preterm Delivery.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 4 countries.

Laura VisserDepartment of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.
Marjon A de BoerDepartment of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.
Christianne J M de GrootDepartment of Obstetrics and Gynecology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.
Tobias A J NijmanDepartment of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Marieke A C HemelsDepartment of Neonatology, Isala Clinic, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Kitty W M BloemenkampDepartment of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Judith E BosmansDepartment 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.
Marjolein KokDepartment of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Judith O van LaarDepartment of Obstetrics and Gynecology, Maxima Medical Center in Veldhoven, De Run 4600, 5504 DB, Veldhoven, The Netherlands.
Marieke SuetersDepartment of Obstetrics and Gynecology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Hubertina ScheepersDepartment of Obstetrics and Gynecology, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Joris van DrongelenDepartment of Obstetrics and Gynecology, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Maureen T M FranssenDepartment of Obstetrics and Gynecology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
J Marko SikkemaDepartment of Obstetrics and Gynecology, Hospital Group Twente, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands.
Hans J J DuvekotDepartment of Obstetrics and Gynecology, Erasmus Medical Center, 's- Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Mireille N BekkerDepartment of Obstetrics and Gynecology, Birth Centre Wilhelmina Children Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Joris A M van der PostDepartment of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Christiana NaaktgeborenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Ben W J MolDepartment of Obstetrics and Gynecology, Robinson Research Institute, University of Adelaide, 72 King William St, North Adelaide, SA 5006, Australia.
Martijn A OudijkDepartment of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. m.a.oudijk@amc.uva.nl.
Academic Medical Center · NLAmsterdam UMC Location VUmc · NLUniversity Medical Center Utrecht · NLHeidelberg University · DEIsala · NLLeiden University Medical Center · NLMaastricht University · NLMáxima Medisch Centrum · NLRadboud University Nijmegen · NLUniversity Hospital Heidelberg · DEUniversity Medical Center Groningen · NLUniversity of Adelaide · AUVrije Universiteit Amsterdam · NLZiekenhuis Groep Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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 registrationClinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.

Indexed as

AdolescentAdultAspirinCost-Benefit AnalysisDouble-Blind MethodFemaleGestational AgeHumansObstetric Labor, PrematurePlatelet Aggregation InhibitorsPregnancyPregnancy OutcomePrenatal CareRecurrenceSecondary PreventionTreatment OutcomeAspirinPlatelet Aggregation InhibitorsAcetylsalicylic acidASAAspirinPregnancyPreterm birthPreterm labourPreventionPTBReduction‘Spontaneous recurrent preterm birth’SPTB

Identifiers

PMID28705190
PMCPMC5513323
OpenAlexW2736131707

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.