Aspirin for the prevention of spontaneous preterm birth

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29647

Enrollment

406

Registered

2016-01-22

Start date

2016-05-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnancy, recurrent preterm birth, recurrent preterm labour, pretem birth, preterm labour, PTB, prevention, aspirin, ASA zwangerschap, herhaalde vroeggeboorte, vroeggeboorte, preventie, aspirine preterm delivery, prematurity

Interventions

Laaggedoseerde aspirine (80 mg)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Preterm birth, defined as birth at a gestational age less than 37 weeks.	—

Secondary

Measure	Time frame
Composite 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.	—

Measure

Time frame

Composite 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.

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Contacts

Public ContactAnadeijda J.E.M.C. Landman

Amsterdam UMC

a.landman@amsterdamumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)