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van CCT (UK)

van CCT (UK)

Low dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour the APRIL study

- candidate number23640
- NTR NumberNTR5675
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2016
- Secondary IDsABR 54463
- Public TitleLow dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour the APRIL study
- Scientific TitleLow dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour the APRIL study
- hypothesisUse of low dose aspirin from 10 - 36 weeks of gestational age wil generate a in reduction of recurrent spontaneous preterm birth from 36% to 23%
- Healt Condition(s) or Problem(s) studiedPregnancy, Preterm birth, Aspirin, Prevention
- Inclusion criteria- Pregnant women
- >18 years of age
- History of spontaneous preterm birth (Spontaneous preterm birth is defined as: birth following spontaneous contractions with intact membranes or birth after preterm ruptured membranes at a gestational age between 22 and 37 weeks)
- Exclusion criteria- Other indication for aspirin during pregnancy
- History of Indicated PTB for maternal reasons such as preeclampsia or HELLP
- History of indicated PTB for fetal reasons such as IUGR
- Fetal abnormalities in current pregnancy
- Multiple pregnancy either in the prior preterm birth pregnancy or current pregnancy
- Thrombocytopenia, thrombocytopathy
- Indications for the use of anticoagulants
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jul-2018
- Target number of participants406
- InterventionsLow dose aspirin 80mg 1x/day versus placebo, initiated from 8-16 week up to 36 weeks of gestation.
- Primary outcomePreterm birth, defined as birth at a gestational age less than 37 weeks.
- Secondary outcomeComposite of poor neonatal outcome, the individual components of the composite perinatal outcome, number of days on ventilation support (ventilation and /or respiratory support by Continuous Positive Airway Pressure (CPAP)), infant respiratory distress syndrome (IRDS) that requires treatment with surfactant, patent ductus arteriosus (PDA) that requires treatment, cerebellar bleeding, days of admission on the NICU, convulsions, asphyxia, proven meningitis, pneumothorax and total days in hospital until 3 months corrected age.
Maternal outcomes; maternal side effects, maternal mortality, hospital admissions, maternal morbidity, placental abruption, maternal infection or inflammation, major ante- or post-partum haemorrhage. Subgroup analyses will be performed for women with a previous preterm birth before and after 30 and 34 weeks GA, contractions with intact membranes versus PPROM, women treated with progestagens versus no additional treatment, women with a short cervix ( < 25 mm) in the current pregnancy and women initiating low dose ASA < 12 weeks versus 12-16 weeks of gestation.
- TimepointsInclusion will have tot take place < 16 weeks of gestational age. Subjects will use the medication until 36 weeks gestational age.
Neonatal en maternal data will be collected until final dischrage from the hospital after delivery.
- Trial web
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-jan-2016 - 20-mrt-2016

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