Long-term follow-up of children exposed in utero to low-dose aspirin for prevention of preterm birth, a follow-up of the APRIL trial

Long-term follow-up of children exposed in utero to low-dose aspirin for prevention of preterm birth, a 4 year follow-up of the APRIL trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21183

Enrollment

200

Registered

2020-10-02

Start date

2020-07-01

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

Prevention of preterm birth in multiple pregnancy

Interventions

Low dose aspirin

Eligibility

Inclusion criteria

Inclusion criteria: All mothers and their child that participated in the APRIL trial. Mortality data of all children up to 4 years will be collected. Surviving children will be assessed at 4 years corrected age (ranging between 45 months and 51 months calculated from the expected date of delivery).

Exclusion criteria

Exclusion criteria: Women that withdraw their consent after randomization in the original APRIL trial. Women that did not gave consent to be approached for follow-up during the original APRIL trial.

Design outcomes

Primary

Measure	Time frame
(neuro)development and behaviour	—

Secondary

Measure	Time frame
Mortality (perinatal death and infant death up to 4 years of age), child’s growth and health related problems (i.e. information on surgery, medication use and hospital admissions).	—

Contacts

Public ContactEmilie van Limburg Stirum

Amsterdam UMC

april-fu@amsterdamumc.nl003120566740

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)