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临床试验/NCT06264973
NCT06264973招募中不适用

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

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum using mmol/l

研究概览

简要总结

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.

详细描述

A clinical observational study will be performed in women admitted at the Department of Obstetrics at the Sophia Children's Hospital/Erasmus MC for suspicion of preterm birth with a gestational age of 23+5 weeks until 33+6 weeks. Antenatal corticosteroids will be administered according to the local standard protocol (12 mg betamethasone intramuscular with a 24 hours intervall). Importantly, clinical management of women with suspicion of preterm birth will not be affected by the proposed study. After inclusion, repetitive blood sampling according to the following schedule: t0 (administration), t0-30 min, t10-12hrs and t20-24 hrs. Umbilical cord will be sampled directly after birth as fetal determinant in which corticosteroids and their metabolites will be measured. Also, neonatal blood samples (drawn by the paediatricians as part of standard care) will be used for measurement of corticosteroids and their metabolites. Maternal blood samples will furthermore be analysed for determinants effecting pharmacokinetics such as oestradiol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 2 days

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

次要结局

  • 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)
  • PE by urine measurement of protein-creatinine ratio(2 days)
  • Oestradiol concentration in serum in mmol/l(2 days)
  • Cord blood and neonatal blood concentration in mmol/l of corticosteroids(Delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sam Schoenmakers

Gynaecologist, perinatologist

Erasmus Medical Center

研究点 (1)

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