ID
Bron
Verkorte titel
Aandoening
Prevention of preterm birth in multiple pregnancy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
(neuro)development and behaviour
Achtergrond van het onderzoek
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).
Onderzoeksopzet
4 years
Onderzoeksproduct en/of interventie
Low dose aspirin
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8950 |
| Ander register | METC AMC : W20_289 # 20.325 |