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Stress Disorders, Post-TraumaticNCT02370576

The Effect of Traumatic Childbirth on the Incidence of PTSD and Other Major Postpartum Psychopathology

An observational study of Stress Disorders, Post-Traumatic and Depressive Disorder, Major, run by Rambam Health Care Campus at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
rating scale application
How many people
500 participants
Where
1 siteIsrael
Study dates
Mar 2015to Mar 2018
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Either healthy women without previous psychiatric background,1-2 days after an uncomplicated planned Cesarean birth, or healthy women without previous psychiatric background, 1-2 days after an emergency Cesarean birth.

Who may be able to join

  • No psychiatric background

Who cannot join

  • Known psychiatric disorder

Trial locations and contacts

1 site in 1 country.

Marina Bar-Shai, MD, PhD contact

972-50-2062142

m_bar-shai@rambam.health.gov.il

Israel1 site
  • Rambam Medical Center

    Haifa

    Marina Bar-shai, MD, PhD, 972-50-2062142, m_bar-shai@rambam.health.gov.il

Other trials in Israel

About this study

Official title: The Effect of Traumatic Childbirth on the Incidence of Postpartum PTSD, MDD and Anxiety Disorders

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.

Read the detailed 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.

Being tested
rating scale application
Medical subject headings
Stress Disorders, Post-Traumatic, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rating scale applicationOther

    Also called rating scale

    Administration of validated PTSD, MDD and anxiety disorders rating scales immediately after birth and 1 month postpartum.

    rating scale application

Study groups in NCT02370576
Study groupRoleWhat they receive
controlHealthy women after elective cesarean section.Questionnaire/ rating scale application. Screening: protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).
Receives: Other: rating scale application
emergencyHealthy women after emergency cesarean section. Questionnaire/ rating scale application. Screening: protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).
Receives: Other: rating scale application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence or absence of PTSD (Questionnaire/ rating scale application)

    Measured: 1 month

Secondary outcomes (2)
  1. Presence or absence of major depression (Questionnaire/ rating scale application)

    Measured: 1 month

  2. Presence or absence of anxiety disorders (Questionnaire/ rating scale application)

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT02370576
Sponsor's protocol ID
rambam001
Status last verified
Feb 2015
First submitted
15 Feb 2015
Last updated
25 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Stress Disorders, Post-Traumatic and Depressive Disorder, Major, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marina Bar-Shai, MD, PhD (972-50-2062142, m_bar-shai@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence or absence of PTSD (Questionnaire/ rating scale application) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.

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