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

NCT06264973 | Recruiting DMC

• 1 other identifier: NL9318
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum using mmol/l

  To examine the pharmacokinetics in maternal blood of standard regimen at the Erasmus MC of two doses of 12 mg betamethasone intramuscular with a 24 hours interval

  2 days

Secondary Outcomes (8)

• Maternal age

  2 days

• Fetal sex

  2 days

• Maternal weight/BMI in kg and kg/m2

  2 days

• Number of fetus

  2 days

• Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more

  2 days

Other Outcomes (1)

• CYP3A4 level

  2 days

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women 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. Postpartum, the neonates will also be included in the study.

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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sam Schoenmakers, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Schoenmakers, MD, PhD

CONTACT

0031107037439; s.schoenmakers@erasmusmc.nl

Emma Ronde-Salminen, MD

CONTACT

0031683997312; e.ronde@erasmusmc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynaecologist, perinatologist

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: February 20, 2024
• Study Start: January 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)