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
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C05C) CAPILLARY STABILIZING AGENTS
CAPILLARY STABILIZING AGENTS
Population studied

Short description of the study population

Pregnant women who were either exposed or unexposed to veinotonics and who delivered from July 1st 2004 to December 31th 2007 in Haute-Garonne were registered in the French Health Insurance Service-EFEMERIS database have been included.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)

Special population of interest

Pregnant women

Estimated number of subjects

37000
Study design details

Main study objective

The main objective is to investigate potential adverse drug reactions of veinotonics in pregnancy.

Outcomes

all-cause pregnancy loss, preterm birth, small for gestational age, neonatal pathology, congenital malformation

Data analysis plan

We compare pregnancy outcomes and newborn health between women exposed to veinotonics during pregnancy and unexposed women. Multivariable cox proportional hazards regressions are used to estimate hazard ratios with 95 % CIs, comparing the hazard rates of pregnancy termination and preterm birth between exposed and unexposed women. Multivariable conditional logistic regressions with 95 % CIs are used to analyze the effect of exposure to veinotonics on the risks of small for gestational age, neonatal pathology, and congenital malformation.
Documents
Study publications
Lacroix I, Beau AB, Hurault-Delarue C, Bouilhac C, Petiot D, Vayssière C, Vidal…