premature contractions Preterm birth
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion 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. 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.
Exclusion criteria
Exclusion criteria: 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 maternal and fetal (as measured in umbilical cord blood sampling directly after birth) pharmacokinetics of standard regimen at the Erasmus MC of two doses of 12 mg betamethasone intramuscular with a 24 hours interval for pregnant women suspected of preterm birth with a gestational age between 23+5 until 33+6 weeks. Farmacokinetic parameters, which will be determined are: distribution (VD), clearance (Cl), elimination-rate constant (kel), steady-state concentration (Css), half-life (t1/2), bioavailability (F). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To examine the relation between CUYP3A4 genotype and the pharmacokinetics of the primary objective. - To examine the relation between maternal age and the pharmacokinetics of the primary objective. - To examine the relation between fetal sex and the pharmacokinetics of the primary objective. - To examine the relation between maternal weight/BMI and the pharmacokinetics of the primary objective. - To examine the relation between the number of fetus and the pharmacokinetics of the primary objective - To examine the relation between parity the pharmacokinetics of the primary objective. - To examine the relation between pre-eclampsia and the pharmacokinetics of the primary objective - To examine the relation between oestradiol on pharmacokinetics of the primary objective - To examine the relation between pharmacokinetics in cord blood and neonatal blood | — |
Countries
Netherlands
Outcome results
None listed