O60.0
Conditions
Interventions
Group 1: - Steroid prophylaxis with 2 x 3 ampoules of Celestan solubile intravenously over 48 hours
(Composition of one ampoule of Celestan solubile: 4.0 mg betamethasone dihydrogen phosphate)
- 15 se
Sponsors
Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Intact singleton pregnancy - Gestational age between 23+0 and 33+6 weeks at study inclusion - Threatened preterm birth with indication for antenatal steroid prophylaxis in accordance with current medical standards
Exclusion criteria
Exclusion criteria: - Multiple pregnancies - Triple I (amniotic infection syndrome) - Therapy with systemically active corticosteroids within the last seven days prior to study inclusion and during the measurement periods - Incapacity to give consent - Impaired liver function (ASAT/ALAT > 2x the upper normal value) - Anemia with hemoglobin concentration < 6.0 mmol/L - Cardiac valve defects = II°, signs of cardiac insufficiency (= NYHA III) Study protocol BetaIV, version 2.1 - Birth within 48 hours after the start of antenatal steroid prophylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential measurement of the betamethasone concentration in maternal plasma with determination of the concentration–time curve, the maximum plasma concentration of betamethasone, the time to reach maximum concentration, and the plasma half-life of betamethasone, as well as the minimum concentrations at 24 hours and 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of the study is to compare the above-mentioned parameters following intravenous administration with those observed for other routes of administration. | — |
Countries
Germany
Contacts
Public ContactJohannes Stubert
Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock
Outcome results
None listed