protocolSection identificationModule nctId: NCT06264973, orgStudyIdInfo id: NL9318, briefTitle: Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy, acronym: MaDyCo, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy., conditionsModule conditions: Preterm Birth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum, secondaryOutcomes measure: Maternal age, secondaryOutcomes measure: Fetal sex, secondaryOutcomes measure: Maternal weight/BMI, secondaryOutcomes measure: Number of fetus, secondaryOutcomes measure: Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more, secondaryOutcomes measure: PE by urine measurement of protein-creatinine ratio, secondaryOutcomes measure: Oestradiol concentration in serum, secondaryOutcomes measure: Cord blood and neonatal blood, otherOutcomes measure: CYP3A4 level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, status: RECRUITING, city: Rotterdam, state: Zuid Holland, zip: 3015GD, country: Netherlands, contacts name: Sam Schoenmakers, MD, PhD, role: CONTACT, phone: +31107037439, email: s.schoenmakers@erasmusmc.nl, contacts name: Emma Ronde-Salminen, MD, role: CONTACT, phone: 0031683997312, email: e.ronde@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False