Investigating corticosteroids in pregnant women at risk of preterm birth

Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy as Treatment for Fetal Lung Maturation MaDyCo-study

This study is testing how well corticosteroids work in pregnant women at risk of giving birth too early to see if it can help improve outcomes for both mothers and their babies.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT06264973 on ClinicalTrials.gov

What this trial studies

This observational study aims to improve pregnancy outcomes by examining the pharmacokinetics and dynamics of antenatal corticosteroids administered to women at risk of preterm birth. Women admitted to the Department of Obstetrics at Erasmus MC with a gestational age between 23+5 and 33+6 weeks will receive corticosteroids according to standard protocols. Blood samples will be collected from mothers and neonates to measure corticosteroid levels and their metabolites, providing insights into optimal dosing regimens. The study will not alter the clinical management of the participants.

Who should consider this trial

Good fit: Ideal candidates are pregnant women over 18 years old, admitted for suspicion of preterm birth between 23+5 and 33+6 weeks of gestation.

Not a fit: Patients with acute obstetric complications requiring immediate delivery or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dosing strategies for corticosteroids, enhancing neonatal outcomes for preterm infants.

How similar studies have performed: While the use of antenatal corticosteroids is standard, this study's focus on pharmacokinetics and dynamics is novel and has not been extensively tested.

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.

Where this trial is running

Rotterdam, South Holland

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

Study contacts

• Principal investigator: Sam Schoenmakers, MD, PhD — Erasmus Medical Center
• Study coordinator: Sam Schoenmakers, MD, PhD

Conditions Preterm Birth