Maternal and fetal/neonatal pharmacokinetics and - dynamics of corticosteroids during pregnancy as treatment for fetal lung maturatio
- Conditions
- premature contractionsPreterm birth10010273
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
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.
In order for the neonate to be able to participate in this study, the parent
must meet the following criteria:
5) Older than 18 years of age.
6) 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.
7) Understanding of Dutch in speaking and reading.
8) Written informed consent for the neonate.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To examine the maternal and fetal (as measured in umbilical cord blood sampling<br /><br>directly after birth) pharmacokinetics of standard regimen at the Erasmus MC of<br /><br>two doses of 12 mg betamethasone intramuscular with a 24 hours interval for<br /><br>pregnant women suspected of preterm birth with a gestational age between 23+5<br /><br>until 33+6 weeks. Farmacokinetic parameters, which will be determined are:<br /><br>distribution (VD), clearance (Cl), elimination-rate constant (kel),<br /><br>steady-state concentration (Css), half-life (t1/2), bioavailability (F).</p><br>
- Secondary Outcome Measures
Name Time Method