Observe the adherence rate of antidepressants during pregnancy and secondary exploration of possible factors which contribute to non-adherence
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adherence rate of antidepressants during pregnancy
Secondary outcome
-
Background summary
Relapse of depression during pregnancy may be harmful for mother and foetus. A
main risk factor for relapse is non-adherence of pharmacotherapy
(antidepressants). Data about adherence of antidepressants during pregnancy are
lacking. This observational study will focus on the adherence rate of
antidepressants during pregnancy.
Study objective
Observe the adherence rate of antidepressants during pregnancy and secondary
exploration of possible factors which contribute to non-adherence
Study design
All pregnant women with psychiatric morbidity may encounter the special program
for this population in our hospital. Those women with antidepressants will be
asked to participate in this observational study. During pregnancy as much as
possible, within all trimesters the adherence rate will be measured by special
MEMS-packages provided by the department of clinical pharmacy. Data from public
pharmacies of refill rates will be used to determine inside base-line adherence
rates. Adherence rate will be defined as a percentage of MEMS-openings and
number of openings according to the doctor*s prescription. Women will be asked
for TDM monitoring and taking blood samples when antidepressants will be
dispensed. Parameters of influence will be collected: age, height, weight,
demographic parameters, and a standardised questionnaire (DAI, BMQ and for once
an in-house developed questionaires about beliefs of antidepressants during
pregnancy.
Study burden and risks
Not applicable. Blood withdrawal for TDM is part of normal treatment. Drug
dispensing is a normal routine procedure.
Dr van Heesweg 2
8025 AB
NL
Dr van Heesweg 2
8025 AB
NL
Listed location countries
Age
Inclusion criteria
Patients will be included if they are pregnant, use antidepressants, regardless pharmacological class, and signed informed consent.
Exclusion criteria
Incapacity to follow the study protocol according to the attending specialist.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-011893-13-NL |
| CCMO | NL27726.075.09 |