Aim of this study is to identify how pregnancy complications can be predicted from the interplay between psychological, social and somatic risk factors. We hypothesize that the personality trait neuroticism predisposes to complications of pregnancy…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is obstetric outcome in terms of complications. Main
predictors of pregnancy outcome that will be investigated are neuroticism,
social and somatic risk factors and mental disease (anxiety and depression).
Secondary outcome
Secundary endpoint is the severity of complications.
Background summary
About 20% of pregnancies is complicated by some form of maternal or fetal
morbidity. Evidence is mounting that besides somatic risk factors,
psychological and social factors are involved in the etiology of pregnancy
complications. However, the mechanisms that explain how these factors may lead
to pregnancy complications have not been identified yet. A better understanding
of these mechanisms may contribute to improvement of prevention protocols.
Study objective
Aim of this study is to identify how pregnancy complications can be predicted
from the interplay between psychological, social and somatic risk factors. We
hypothesize that the personality trait neuroticism predisposes to complications
of pregnancy and that this relationship is mediated by social risk factors,
somatic disease and mental illness.
Study design
A longitudinal observational design is applied.
Study burden and risks
At 10-14 weeks* gestation, participants complete a series of questionnaires,
that target personality, social factors, anxiety, and depression (time
investment: 1 hour). At 20, 24, 28, 32, and 36 weeks* gestation anxiety and
depressive symptoms are re-assessed (15 minutes), at 32 and 36 weeks in
combination with social factors (30 minutes). Questionnaires are sent to the
home address of participants and can be returned by mail. To establish the
presence of an anxiety and/or depressive disorder a diagnostic interview will
be conducted in women with symptom levels above pre-defined cut-off scores
(interview by phone, 15 minutes). All assessments are non-invasive and bear no
risk with respect to the course or outcome of pregnancy.
Postbus 466
8901 BG Leeuwarden
Nederland
Postbus 466
8901 BG Leeuwarden
Nederland
Listed location countries
Age
Inclusion criteria
- Age over 17 years.
- Sufficient control of the Dutch language.
- Singleton pregnancy.
- Gestational age < 98 days.
Exclusion criteria
- Present somatic or mental disease necessitating hospital admission.
Design
Recruitment
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 |
|---|---|
| CCMO | NL14862.099.06 |