Maternal and fetal/neonatal pharmacokinetics and - dynamics of corticosteroids during pregnancy as treatment for fetal lung maturation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25709

Enrollment

100

Registered

2021-01-14

Start date

2021-01-01

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

(Imminent) preterm birth

Interventions

Corticosteroids

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
To examine the pharmacokinetics in maternal blood of standard regimen	—

Secondary

Measure	Time frame
To examine the relation between diverse maternal factors and the pharmacokinetics of the primary objective.	—

Contacts

Public ContactSam Schoenmakers

Erasmus University Medical Centre

s.schoenmakers@erasmusmc.nl+31616320350

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)