Individual blood concentrations with the same dosing regime
ID
Bron
Verkorte titel
Aandoening
(Imminent) preterm birth
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To examine the pharmacokinetics in maternal blood of standard regimen
Achtergrond van het onderzoek
Preterm birth (PTB), occurring in 1015% of all pregnancies, is the leading cause of perinatal mortality and morbidity with longterm adverse consequences for postnatal health. The outcome after preterm birth was largely improved by the clinical introduction in the 70’s of antenatal corticosteroids (ACS), which are still administrated in a “one dose fits all”principle. However, it is known for over a decade that several factors influence the available maternal concentrations of ACS, while the safety of the universal dosage regime was recently questioned as prenatal exposure to ACS resulted in a higher incidence of mental and behavioral disorders in childhood. We propose to investigate, reevaluate and optimize the current ACS dosage regime to generate a personalized drug therapy approach to improve preterm neonatal outcome.
Doel van het onderzoek
Individual blood concentrations with the same dosing regime
Onderzoeksopzet
After administration of corticosteroids (t=0), blood samples will be drawn at t0, t0-30 min, t 1-3 hr, t 5-8 hr, t 10-12 hr and t20-24 hr. Measurement of corticosteroid concentration will be performed in maternal and umbilical cord blood by using the validated method of LC-MS/MS chromatography (corticosteroidassay (ISO 15189).
Onderzoeksproduct en/of interventie
Corticosteroids
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) Older than 18 years of age.
2) Admitted at the Department of Obstetrics at Erasmus MC – Sophia for suspicion of preterm birth with a gestational age of 23+5 weeks until 33+6 weeks.
3) Understanding of Dutch in speaking and reading.
4) Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Women unable or unwilling to agree with the procedures.
2) Women unable or unwilling to give written informed consent.
3) Women with acute obstetric complications requiring immediate delivery at time of admission.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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 | NL9318 |
| Ander register | METC Erasmus MC : MEC-2019-0650 |