No registrations found.
ID
Source
Brief title
Health condition
(Imminent) preterm birth
Sponsors and support
Intervention
Outcome measures
Primary outcome
To examine the pharmacokinetics in maternal blood of standard regimen
Secondary outcome
To examine the relation between diverse maternal factors and the pharmacokinetics of the primary objective.
Background summary
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.
Study objective
Individual blood concentrations with the same dosing regime
Study design
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).
Intervention
Corticosteroids
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
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 | NL9318 |
| Other | METC Erasmus MC : MEC-2019-0650 |