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ID
Source
Brief title
Health condition
Prevention of preterm birth in multiple pregnancy
Sponsors and support
Intervention
Outcome measures
Primary outcome
(neuro)development and behaviour
Secondary outcome
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).
Background summary
Rationale: Low-dose aspirin is frequently used in obstetric clinical practice for the prevention of pre-eclampsia and fetal growth restriction. There are no perinatal or maternal harms of aspirin use during pregnancy. However, long-term health data of children exposed to aspirin
in utero is lacking.
Objective: To assess the long-term effect of in-utero exposure to low-dose aspirin compared to placebo on child (neuro)development, behavior and health.
Study design: Long-term follow-up of 4-year old children born to mothers from the APRIL trial who were randomized between low-dose aspirin (80 mg) and placebo. Study medication started between 8- and 16-weeks gestation and continued up to 36 weeks gestation or delivery, whichever came first.
Study population: All women that participated in the APRIL trial (n=406) and their children at four years corrected age.
Main outcomes: (neuro)development and behaviour.
Additional outcomes: 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).
Study design
4 years
Intervention
Low dose aspirin
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
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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8950 |
| Other | METC AMC : W20_289 # 20.325 |