Our objective is to test the following hypotheses : - Hypothesis 1 (part 1 of the study): The stress reduction intervention has beneficial effects on subjective maternal emotional well-being, on objective maternal stress system measures (i.e., HPA-…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
- Cognitive and attention disorders and disturbances
Synonym
Health condition
aangeboren kwetsbaarheid gerelateerd aan het stresssysteem (HPA-as en autonoom zenuwstelsel)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Part 1 (sample 1 : measuring at 10-14, 24 and 34 weeks of pregnancy)
-Measures of anxiety, stress, and mindfulness with self-report questionnaires:
Stress (Cohen Self Perceived Stress Scale), general anxiety (Spielberger State
Trait Anxiety Scale), specific pregnancy anxiety (Pregnancy Anxiety
Questionnaire-R) en Mindfulness (Five Factor Mindfulness Questionnaire)
-basal HPA-as activity: saliva samples to measure cortisol awakening response
and diurnal cortisol profile
-basal ANS activity: saliva samples to measure alpha-amylase; 24 hrs ambulant
monitoring with VU-ambulant monitoring system
-stress-related HPA-axis activitity: saliva samples to measure cortisol before
and after a stress-inducing arithmetic Pc-task
-stress-related ANS-activity: heart rate variability (HRV) measures with
commercial equipment (BIOPAC systems Inc,) before during and after a
stress-inducing arithmetic Pc-task
2. Part 2 (sample 2 : measures in the four month old infant)
-measuring of cognitive functioning with AERPs-paradigma
-stress-related ANS activity: measures of HRV before, during and after
AERPs-paradigma (with BIOPAC software)
-stress-realated HPA-activity: saliva samples to measure cortisol before and
after AERPs
3. Part 3 (sample 1: measure in the mother and her infant when the infant is
four months old)
-for the baby: the infants are tested with the protocol that is set up and fine
tuned in part 2.
-for the mother: well-being of the mother (psychological measurements) and
basal HPA-axis activity as described in part 1; There are no ambulant
recordings of ANS and no stress-induced HPA-axis of ANS activity measures.
-some aspects of cognitive and socio-emotional development of the infant will
be measured with subscales of the Ages and Stages Questionnaire (ASQ) and the
ASQ: Social- Emotional version and an infant temperament scale (IBQ-R). These
measures will be used as covariates and in some analyses also as moderators.
-length of gestation, birth weight, birth length, obstetrical characteristics
are taken from the medical file
Secondary outcome
covariates
mother: maternal age, parity, gravidity, body mass index, education, SES,
ethnicity, smoking, alcohol, glucocorticoid exposure, prescription drug use
(i.e., SSRI, anti-hypertensive, anti-asthmatic, anti-epileptic, steroids..)
Background summary
A large body of research provides empirical evidence for the hypothesis that
the risk of a shorter length of gestation and of late preterm birth is
increased when maternal chronic stress is present. The interaction between the
maternal stress system and the physiology of pregnancy and parturition is seen
as one of the pathophysiological mechanism explaining preterm birth. There is
also evidence for an association between maternal stress and anxiety during
pregnancy and birth defects in the offspring, including cognitive functioning.
Moreover it is hypothesized that antenatal exposure to maternal chronic stress
may induce morphological and functional changes in the hippocampus, amygdala
and prefrontal cortex by which a neurobiological vulnerability is acquired
already prenatally. There still is, however, a lack of knowledge about the
underlying mechanisms. On the one hand a better understanding of the biology of
preterm parturition and of (subtle) birth defects and their underlying
pathophysiological processes is necessary to set up preventive and curative
treatment of women at enhanced risk for giving birth to babies with birth
defects and/or for preterm parturition. On the other hand, by examining in
pregnant women the effectiveness of a standardized stress reduction
intervention program on maternal stress systems and also the infant stress
system and cognitive functioning, hypotheses about the proposed underlying
mechanisms will have a chance to be tested
Study objective
Our objective is to test the following hypotheses :
- Hypothesis 1 (part 1 of the study): The stress reduction intervention has
beneficial effects on subjective maternal emotional well-being, on objective
maternal stress system measures (i.e., HPA-axis and/or ANS measures) and on
length of gestation.
- Hypothesis 2 (part 2 of the study): In normal four months old infants the
maturity of its stress system (as measured with HPA-axis and ANS measures) is
associated with their cognitive functioning (as measured with auditory
event-related evoked potentials ( AERPs).
- Hypothesis 3 (part 3 of the study): The association between the infant stress
system and its cognitive functioning (as measured with AERPs in the four month
old infant) is moderated by the maternal stress system during pregnancy.
Hypothesis 3 is the most explorative one. We assume that: (a) the moderating
influence of the maternal system may occur independently of whether the mother
participated in the stress reduction intervention or not; (b) if the
intervention is associated with a reduction of birth defects, this most
probably is related to benefical effects of the intervention not only on
subjective well-being but also on the maternal stress system.
Study design
The first part of our proposed study involves a randomized controlled trial
(sample 1, n=140) in which 70 women receive a stress reduction intervention,
weekly between week 15 and 23 of gestation, and 70 matched women receive normal
prenatal care. It will be examined whether the intervention has an influence on
subjective well-being and on maternal autonomic regulation and HPA-axis
function as well as on length of gestation. We hypothesize that, if the
provided intervention is effective, it may indeed influence the length of
gestation and eventually lower the chance for premature delivery (hypothesis
1). As a recent study showed that there is a 23% decrease in adverse outcomes
with each week of advancing gestational age between 32 and 39 completed, even a
gain of one gestational week is an important goal to obtain.
In the second part of our study, we design a protocol to study the association
between the autonomic regulation (i.e., heart rate variability measures),
HPA-axis (i.e., cortisol responsiveness) and cognitive functioning (i.e.,
attention to auditory events and cortical auditory processing as measured with
auditory event-related potentials) in a sample of four months old infants
(sample 2, n=60). Positive associations between these systems are expected
(hypothesis 2).
Finally, in the third part, with the protocol tested in the second part, an
eventually enhanced vulnerability acquired during gestation in the offspring of
the stressed or anxious women of sample 1 will be examined when the offspring
is four months old. It plausible to hypothesize that the maternal stress system
during pregnancy moderates this effect (hypothesis 3, the most explorative
one). This moderating influence may occur independently of whether the mother
participated in the stress reduction intervention or not. If the intervention
is associated with a reduction of birth defects, this most probably is related
to beneficial effects of the intervention not only on subjective well-being but
also on the maternal stress system.
Intervention
A stress reduction intervention is given to the experimental group, weekly
between week 15 and 23 of gestation and each session lasts 150 minutes,
Study burden and risks
Completing the questionnaires takes 15 to 30 minutes; taking the saliva samples
takes a few minutes every time; to attach and detach the VU-ambulant monitoring
system will take 10 minutes.
The observations in the university lab (3 times during pregnancy) take about 60
minutes
For the Mindfulness-training (to reduce stress) therer are 8 sessions that last
150 minutes each
The final observation in the lab takes 60 to 75 minutes and completion the
questionnaires takes 30 minutes.
Postbus 905153
5000 LE Tilburg
NL
Postbus 905153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Pregnant woman:
-18 to 40 year old
-score higher then Pc 67 on standardised stress and anxiety questionnaires
-no substance abuse problems
-no severe psychiatric problems
-no pregnancy-related medical problems (e.g. diabetes, hypertension) or obstetrical problems;Babies
-their mothers score lower than Pc 50 on standardized stress and anxiety questionnaires, measuring concurrent stress and anxiety
- their mothers score lower than Pc 50 on standardized stress and anxiety questionnaires retrospectively measuring their experience of stress and anxiety during pregnancy;
- the babies were full term at birth and there were no pregnancy or birth complication, no neurological impairment, congenital malformation or disease for which extensive medical treatment was needed.
Exclusion criteria
Pregnant woman:
-other medical or obstetrical complications during this pregnancy
-18 to 45 year old
-score lower then Pc 67 on standardised stress and anxiety questionnaires
-substance abuse problems
-severe psychiatric problems
-pregnancy-related medical problems (e.g. diabetes, hypertension)
or obstetrical problems;Babies
- their mothers score higher than Pc 50 on standardized stress and anxiety questionnaires, measuring concurrent stress and anxiety
- their mothers score higher than Pc 50 on standardized stress and anxiety questionnaires retrospectively measuring their experience of stress and anxiety during pregnancy;
- the infants were preterm born and there were pregnancy or birth complications, neurological impairments, a congenital malformation or disease for which extensive medical treatment was needed.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL30051.008.09 |