A prospective evaluation in a hospital setting on the frequency of post-traumatic stress disorder (PTSD) and post-traumatic stress (PTS) symptoms, following a severe post-partum hemorrhage (PPH) of 2,0 liters or more, compared to deliveries without…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. PTSD diagnosis
2. No PTSD diagnosis
Secondary outcome
1. Post-traumatic stress symptoms (based on DSM-5 criteria of PTSD)
B: Intrusion
C: Avoidance
D: Negative cognitions and mood
E: Hyper arousal
F: Duration symptoms
G: Functional significance/influence on life
Co-morbidity: alcohol, drug, medication abuse
Search for psychological treatment
2. No post-traumatic stress symptoms
Background summary
Post-traumatic stress disorder (PTSD) is an anxiety disorder resulting from
exposure to an event that is considered as traumatic. PTSD symptoms are
intrusion, avoidance, negative cognitions and mood, and hyper arousal, as
described by the DSM-5. It was first described and is best known in relation to
war traumas, but is now also recognized in relation to any potential traumatic
event. For example, it was shown that a near death experience during cardiac
arrest can lead to PTSD. Also, the form of exposure to the event may differ,
both victims as well as spectators can develop PTSD. The life time prevalence
of PTSD in the Netherlands is 7.4%.
Previous studies have shown a PTSD prevalence in women as a result of traumatic
childbirth between 0.0 * 5.9 % worldwide, and 1.0- 3.0% in Western countries.
A large study in the Netherlands showed a 1.2% prevalence rate, which is around
2000 women per year.
Witnesses of traumatic birth, such as partners and health care providers, also
have a risk of developing PTSD and depression. Several studies have been done
to explore obstetrical and patient characteristic risk factors in partners.
Although there is a lack of good qualitative and quantitative studies, the
prevalence of PTSD is estimated between 0,0 and 5,0% 6 weeks post-partum. One
Dutch study showed that symptoms of depression and PTSD during the pregnancy
experienced by the woman, give a higher risk of the partner developing PTSD and
depression after birth complications, such as pre-eclampsia or preterm prelabor
rupture of membranes (PPROM). However, the common idea of the prevalence, risk
factors and treatment for PTSD and PTS-symptoms in partners and health care
providers needs further investigation. Our clinical experience is that partners
often experience a sense of uncertainty and powerlessess, when confronted with
the emergency situation of a PPH.
The definition of a severe PPH is usually blood loss of 2,0 liters or more, but
differs internationally. For example, it is sometimes defined as a hemorrhage
that resulted in a blood transfusion of 4 packed cells or more, or resulted in
an embolization or hysterectomy. The incidence rate of severe PPHs in the
Netherlands is 4.5 per 1000 deliveries. Severe PPH can result in extremely low
blood pressure, lethargy, dyspnea, anuria, and eventually collapse and death.
The most common causes for PPH are uterine atony, retained placenta, vaginal
and cervical tears, placenta praevia and coagulation deficits. Patients often
experience severe PPH as traumatic, describing it as if they were slowly
bleeding to death. Severe hemorrhages of 2,0 liters or more often lead to
emergency situations, whereby women may have a higher risk of developing PTSD,
because the PPH is accompanied by physical symptoms.
Study objective
A prospective evaluation in a hospital setting on the frequency of
post-traumatic stress disorder (PTSD) and post-traumatic stress (PTS) symptoms,
following a severe post-partum hemorrhage (PPH) of 2,0 liters or more, compared
to deliveries without a PPH, both in patients as well as in their partners.
When PPHs show to be a risk factor for PTSD, this may lead to more intensive
follow-up and screening for PTSD in PPH patients in the future.
Study design
This will be a prospective cohort study. First, patients and controls are
selected from the complication and birth registers in 10 hospitals by
designated investigators from each hospital. When patients leave the hospital,
they receive a short information letter, to inform them that they will be
invited for participation 6 to 8 weeks after birth. This information does not
include the content of the research.
The address, phone number and native language of the women are available in the
hospital registers. Since information of partners is usually lacking, a letter
is sent to their home address, addressing both patient and partner in the same
letter. If they are non-Dutch speaking patients, they will receive the letters
and forms in English. This is done 6 weeks after delivery. They are informed
about our study by a patient letter and asked to participate. Attached there
will be two separate informed consents and envelopes; one for the patient and
one for the partner, the same applies for the control patients and partners.
When they sign this form, they agree to participate in our research (see
informed consent). A separate question is added for women that do not want to
participate, asking for permission to use their medical details, so we can
include their partner. We also ask to fill in both their e-mail addresses and
phone numbers. After we receive their informed consent, patient, partner and
controls will receive separate e-mails. This e-mail contains a link to the
website of Surveymonkey with a digital version of the PCL-5 questionnaire. A
first (1 week) and second (2 weeks) reminder will be sent to non-responders
through e-mail.
When a patient scores above our cut off values on the questionnaire, they will
be contacted by phone for a telephone interview. The interview will be the
Clinician Administered PTSD Scale for DSM-5 (CAPS -5), which is the golden
standard for the diagnosis of PTSD. The CAPS-5 is available in Dutch and
English, and both versions are currently being validated. Cut off values will
be based on these studies. Through this interview, the diagnosis of PTSD or PTS
symptoms is either confirmed or rejected.
Study burden and risks
Taking part in the survey means patients have to fill in a questionnaire and do
a telephone interview. This questions may trigger post-traumatic stress
symptoms, which may be experienced as a burder for patients with PTSD. However,
this is a small risk, as patients can choose to pauze or even quit the survey
at any time. When a patient scores above our cut-off values, they are offered
help through their general practitioner (GP). Their GP is informed about the
result of our test and are advised to refer their patient to a specialized
psychologist. This may be beneficial for the course of their potential
disorder. Approval of the patient is asked in the informed consent.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
Group 1 (women):
18 years older
Post-partum hemorrhage of 2,0 liters or more ;Group 2 (partners):
18 years or older
Partner of group 1.1 patient/permission of patient for medical history
Witnessed hemorrhage
Exclusion criteria
Group 1 (women):
Medical history of post-traumatic stress disorder
Inability to speak or read Dutch or English;Group 2 (partner):
Medical history of post-traumatic stress disorder
Inability to speak or read Dutch or English
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL50273.100.14 |
OMON | NL-OMON29566 |