Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C02AB01) methyldopa (levorotatory)
methyldopa (levorotatory)
(C07AG01) labetalol
labetalol
(C08CA05) nifedipine
nifedipine
(C07AB07) bisoprolol
bisoprolol
(C01CA24) epinephrine
epinephrine
(C09CA) Angiotensin II receptor blockers (ARBs), plain
Angiotensin II receptor blockers (ARBs), plain
(C03CA01) furosemide
furosemide
(C04AD03) pentoxifylline
pentoxifylline
(C07AA05) propranolol
propranolol
(C03CA04) torasemide
torasemide

Medical condition to be studied

Pregnancy
Hypertension
Congenital anomaly
Abortion
Foetal death
Stillbirth
Population studied

Age groups

Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

600000
Study design details

Main study objective

To carry out a study on the safety of antihypetensive (AH) drugs during pregnancy, on one hand, and the role of hypertension on pregnancy outcomes, on the other, in an attempt to disentangle the effect of the medications from that of the illness itself, using for this purpose the PREGVAL cohort, constructed with data from the Valencia Health System Integrated Database (VID).

Outcomes

congenital anomalies, abortion, fetal death, stillbirth, neonatal death, Preterm birth, Small for Gestational age.

Data analysis plan

We will conduct 3 separate comparisons in our analyses: 1) women with CH exposed to antihypertensive (AH) medications during the pregnancy period vs women with CH unexposed to AH (control), 2) women with CH unexposed to AH (uncontrolled hypertension-considering blood pressure measures during pregnancy) vs. women with CH unexposed to AH (controlled hypertension-considering blood pressure measures during pregnancy) and, 3) women with CH unexposed to AH (controlled hypertension-considering blood pressure measures during pregnancy) vs. women without CH who did not receive AH medications during the pregnancy period (control). In each analysis, we first will determine the frequency of and unadjusted odds ratio (OR) and 95% confidence intervals (CIs) for the different outcomes. To account for the differences in the baseline characteristics in the groups that are being compared, we will perform propensity score analyses. Then, we will use inverse probability treatment-weighting (IPTW).