Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy

Recruiting now

Conditions studied: Preterm Birth

In brief

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.

Key facts

Study ID

NCT06264973

Run by

Erasmus Medical Center

People needed

100

Starts

2021-01-01

Expected to finish

2025-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Older than 18 years of age.
• 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.
• Understanding of Dutch in speaking and reading.
• Written informed consent.
• In order for the neonate to be able to participate in this study, the parent must meet the following criteria:
• Older than 18 years of age.
• 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.
• Understanding of Dutch in speaking and reading.
• Written informed consent for the neonate.

You may not qualify if…

• Women unable or unwilling to agree with the procedures.
• Women unable or unwilling to give written informed consent.
• Women with acute obstetric complications requiring immediate delivery at time of admission.

Where it is running

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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