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Low dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47921
Enrollment
406
Registered
2016-02-22
Start date
2016-05-31
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

prematurity preterm birth preterm labour

Interventions

Low dose aspirin (80mg) versus placebo, initiated from 8-16 week up to 36 weeks of gestation.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women with a singleton pregnancy with a previous spontaneous preterm birth (in a singleton pregnancy), defined as birth at a gestational age between 22 and 37 weeks

Exclusion criteria

Exclusion criteria: Women with a history of indicated preterm births for maternal reasons such as preeclampsia or HELLP and for fetal reasons such as intra uterine growth restriction.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be premature delivery, defined as a GA

Secondary

MeasureTime frame
Secondary outcomes will be a composite poor neonatal outcome (including BPD, PVL > grade 1, IVH > grade 2, NEC, ROP, culture proven sepsis and perinatal death, number of days on ventilation support, days of admission on the NICU, convulsions, asphyxia, proven meningitis, pneumothorax and total days in hospital until 3 months corrected age. Furthermore preterm delivery

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)