NCT06264973 Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy
| NCT ID | NCT06264973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Preterm Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-01-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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: 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.
Contact & Investigator
Sam Schoenmakers, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06264973 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264973 currently recruiting?
Yes, NCT06264973 is actively recruiting participants. Contact the research team at s.schoenmakers@erasmusmc.nl for enrollment information.
Where is the NCT06264973 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06264973 clinical trial?
NCT06264973 is sponsored by Erasmus Medical Center. The principal investigator is Sam Schoenmakers, MD, PhD at Erasmus Medical Center. The trial plans to enroll 100 participants.