Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02370576 |
| Other study ID # |
rambam001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
February 15, 2015 |
| Last updated |
February 24, 2015 |
| Start date |
March 2015 |
| Est. completion date |
March 2018 |
Study information
| Verified date |
February 2015 |
| Source |
Rambam Health Care Campus |
| Contact |
Marina Bar-Shai, MD, PhD |
| Phone |
972-50-2062142 |
| Email |
m_bar-shai[@]rambam.health.gov.il |
| Is FDA regulated |
No |
| Health authority |
Israel: The Israel National Institute for Health Policy Research and Health Services Research |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Determination of incidence and prevalence of PTSD and other types of psychopathology (such
as anxiety and affective disorders) after traumatic birth experiences and elucidation of
salient risk factors in the local population sample- by prospective follow-up.
Description:
Post- traumatic stress disorder (PTSD)- definitions The criteria for the diagnosis of
traumatic experience involve the experience of a specific traumatic stressor and,
subsequently, four axes of symptoms: (i) re-experiencing of the traumatic event, including
nightmares, intrusive thoughts and emotions; (ii) avoidance of stimuli associated with the
traumatic event; (iii) hyperarousal, expressed as difficulties sleeping or concentrating,
irritability, enhanced startle responses, irritable, aggressive, reckless or
self-destructive behavior and (iv) persistent negative alterations in cognitions and mood.
Formal clinical diagnosis of PTSD can only be made after symptoms have been present for at
least 1 month. The definition of a traumatic event includes the witnessing or experience of
serious threat to life or bodily integrity, or injury (either physical or emotional) to
oneself or others [1]. As such, the subjective and objective experience of giving birth
became recognized as a possibly traumatic event for some women [2]. As a result of a
traumatic childbirth, women may experience general distress, flashbacks, dissociation,
amnesia, sleep disturbances, negative evaluation of self-worth, difficulty breastfeeding,
relationship problems and problems with their own sexuality [3-7], problems with bonding
with their infants [8-12], or significant fear of subsequent childbirth (tocophobia); many
choose not to conceive again for this reason. The afflicted women that do choose to have
further children may insist on a cesarean delivery in hopes that it will not be as traumatic
[6].
PTSD after childbirth- prevalence, risk factors, clinical characteristics and long term
implications About 2- 6% of women will experience the full DSM-V criteria for PTSD at some
point after giving birth [13-14]. An additional 22- 40% may meet the criteria for
subsyndromal PTSD, and another 20-50% of women may report the childbirth experience as
traumatic [13-14].
It is not known at this point what are the characteristics of women who may develop
postpartum PTSD, making it impossible to predict or to prevent this outcome. However,
several risk factors have been recently elucidated. Several predisposing/prenatal factors
associated with the childbirth experience itself have been associated with PTSD. These
include previous psychiatric history [15, 16, 17,18] (especially depression in pregnancy),
socio-demographic problems [19,20, 21] (lack of support, problematic relationship with the
partner), parity (primiparous more at risk), personality traits and disorders [22 -24]
(trait anxiety; anxiety sensitivity, neuroticism), previous trauma [25-26]
- previous childbirth-related trauma; sexual abuse), maladaptive cognitions [27]
(pre-existing, maladaptive schemas; negative cognitive appraisal of past childbirth;
autobiographical memory specificity, fear of upcoming childbirth), nature of delivery
[28, 29] (type and number of interventions; duration, fear of harm to self or baby,
emergency cesarean section (CS), instrumental delivery- especially forceps- assisted,
episiotomy), perception of care from medical staff [24, 29], perception of loss of
control [24, 30], perception of pain [24 ], infant complications [28-29] (especially
low birth weight, low Apgar score, asphyxia, resuscitation, prematurity), and
peritraumatic dissociation [31-32] - feeling of unreality; alterations in perception of
time and place; feeling of disconnection from body). Women having unplanned caesarean
section births were likely to report PTSD-type symptoms. However, there was no
association between PTSD type symptoms and planned caesarean section births [16, 33].
PTSD is also associated with preeclampsia [34-35]. Preeclampsia is associated with both
maternal complications (e.g. eclampsia, abruptio placentae, pulmonary edema, acute
renal failure) [36-37], and perinatal complications (e.g. fetal growth restriction,
preterm delivery, and perinatal death) [38, 39-40]. As previously described, these
adverse pregnancy outcomes are known to be associated with PTSD [41, 43, 44 -46]. Other
seemingly routine aspects of pregnancy may increase vulnerability to active PTSD,
especially in victims childhood sexual trauma or intrafamilial abuse [47, 48, 3-4],
previous pregnancy loss [5,6 ] or prior traumatic birth [7], or when pregnancy is a
result of sexual assault. Inherent physical aspects of pregnancy such as increased
breast sensitivity and fetal movement are potentially triggering. Routine aspects of
prenatal care, including vaginal and breast examinations, can be triggers, especially
for sexual trauma survivors. Labor itself, especially medicalised labor can exacerbate
a sense of powerlessness and vulnerability, which can trigger PTSD symptoms [49].
Physical changes of pregnancy, especially cardiovascular, respiratory, gastrointestinal
and renal system alterations, also could affect the experience of PTSD symptoms [49],
since they might resemble physical sensations associated with anxiety.
It is unclear whether traumatic birth experiences can lead to other types of
psychopathology, such as postpartum depression or anxiety disorders, and more research is
needed to answer this question. However, since there is a known association between
traumatic experiences and affective and anxiety disorders in general- one can surmise that
this association exists also between these disorders and traumatic birth experiences [10,
12, 16].
It is now believed that PTSD severity after childbirth reaches a plateau over the 12 months
postpartum, without further improvement, which means that women with postpartum PTSD do not
spontaneously recover [50]. Thus, many afflicted women develop a chronic disorder that
significantly interferes with their functioning in various areas of life. PTSD during the
postpartum period is an important public health issue because of the longer-term negative
impact of maternal mental health problems on child development [8] including impaired
mother-infant relationship [9-10], delayed intellectual development [11,12 ], and
psychiatric disorder in children [51]. In many PTSD patients the baby can become a constant
reminder of the traumatic birth. Some women report that they felt guilty for blaming the
baby after a traumatic childbirth experience. PTSD within 11 months postpartum is associated
with depression within 11 months postpartum. Little is known about mother-child bonding in
women with PTSD after childbirth, while the negative impact of maternal postnatal depression
on child development has been investigated by different authors showing that especially
chronicity of maternal depression after birth is a predictor for negative development [28,
12].
PTSD after childbirth- pathophysiology Pregnancy is associated with alterations in the
hypothalamic-pituitary-ovarian (HPO) axis, particularly increases in plasma concentrations
of progesterone and estrogen, which can modulate mood and cognition. Pregnancy also is
associated with changes in the hypothalamic-pituitary-adrenal (HPA) axis, including
increases in plasma adrenocorticotropic hormone and cortisol, and a large increase in plasma
corticotropin-releasing hormone, especially in the third trimester (from placental
secretion) [16].
In addition to being a stress hormone, cortisol appears to affect memory, salience, social
cognition, negative mood, [52] alertness and sleep [52]. It is possible that the altered
hormonal milieu of both HPA and HPO axes in pregnancy could affect the expression of PTSD
symptoms by increasing frequency and emotional intensity of traumatic memories, which in
turn affect mood, motivation, social cognition, sleep, and concentration [33].
PTSD after childbirth- assessment tools. Several validated rating scales are in use in PTSD
research. The gold standard is Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which
is rated by a researcher and necessitates time and experience in its administration. PTSD
Symptoms Scale (PSS) and PTSD Checklist for DSM-5 (PCL-5) are self- report short rating
scales. Also in use are depression rating scales such as Montgomery- Asberg Depression
Rating Scale (MADRS, researcher- administered), Major Depression Inventory (MDI, self-
report) and Edingurgh Postnatal Depression Scale (EPDS, self- report, specifically created
to assess the symptoms of peri- and postpartum depression) [53].
Research goals. Determination of incidence and prevalence of PTSD and other types of
psychopathology (such as anxiety and affective disorders) after traumatic birth experiences
and elucidation of salient risk factors in the local population sample- by prospective
follow-up.
Materials and methods We shall apply to the local Helsinki Committee to receive the approval
for the research. The participants will receive an explanation and sign informed consent.
Compare a cohort of women with perinatal complications (emergency CS, instrumental
deliveries, premature labor, serious hemorrhage at childbirth, perineal tear that required
stitching, resuscitation of the newborn, newborn admitted to neonatal intensive care unit)
to a control cohort of healthy women who delivered by elective uncomplicated CS. For women
in both cohorts it should be their first pregnancy and first childbirth. Assess with the
help of rating scales (both researcher- administered and self- report, such as CAPS, PCL-C,
MADRS, MDI, EPDS) in the first two days following childbirth to measure the baseline
parameters and to assess the prevalence of acute stress reaction (ASR) in the research and
the control cohorts. Assess again both cohorts by the above methods 1 month after
childbirth. Compare the prevalence of PTSD between the different cohorts of perinatal
complications and the control cohort. Also- compare the prevalence of PTSD, anxiety and mood
disorders between the different groups of perinatal complications in order to determine
which type of complication carries the greater risk for the development of psychopathology.
Determine whether the development of ASR 2 days after childbirth is predictive of PTSD and
other types of psychopathology 1 month after childbirth. Thus- determine the prevalence of
PTSD and other types of psychopathology 1 month after birth in risk groups versus controls,
prospectively.
