Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

A European multi-centre pregnancy Registry for patients exposed to Eurartesim™ whilst pregnant, Active surveillance
Study drug and medical condition

Name of medicine

EURARTESIM

Medical condition to be studied

Malaria
Population studied

Short description of the study population

The following patients were included in the study:
- Women;
- who have received Eurartesim™ for malaria whilst pregnant, within one (1) month (30 days) before or at any time after conception, or
- whose partner (the biological father) has received any formulation of Eurartesim™ for malaria within one (1) month (30 days) prior to conception (Committee for
Medicinal Products for Human Use, 2005), and
- who have been informed and agree to participate in this study

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

357
Study design details

Main study objective

To assess the live birth incidence of minor and major congenital birth defects following exposure to Eurartesim whilst pregnant or in the one (1) month (30 days) prior to conception.

Outcomes

Estimation of the incidences of birth defects and spontaneous abortion. Frequency and type of pregnancy outcome will be stratified by the earliest trimester of exposure, demographics and medical background characteristics. Pregnancy outcomes will be analysed according to parameters such as lifestyle factors, concomitant medications/infections and medication use.

Data analysis plan

All analysis will be conducted in 2 ways, on all women, and by stratifying the women depending on whether they were directly exposed to Eurartesim or whether the biological father was exposed to Eurartesim.Continuous variables will be described by their mean, SD, median quartiles 1 and 3, extreme values and number of missing data, and compared using student's T test or variance analysis.Categorical variables will be described by the total and % of each response method and the number of missing data, and compared between subgroups using Chi-2 test is the theoretical total of each class studies is greater than 5, and the Fischer test if not. The ordinal variables will be compared between subgroups using a Cochran-Mantal-Haenszel test.Hypothesis formulation will be bilateral and tests will be performed for a first species alpha risk of 5%