Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02306434 |
| Other study ID # |
U-CARE: Pregnancy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 1, 2014 |
| Last updated |
April 11, 2018 |
| Start date |
March 2014 |
| Est. completion date |
March 2017 |
Study information
| Verified date |
April 2018 |
| Source |
Uppsala University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Childbirth related fear is a public health issue strongly related to subsequent reproduction,
a request for caesarean section and women's and children's health. Currently, women are
offered 3-5 counseling sessions with specially trained midwives and obstetricians in most
Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but
research show no major effect on cesarean section rates neither in decreased level of
childbirth related fear. It is therefore important to find the best available treatment for
this issue.
The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with
standard counseling care for pregnant women reporting childbirth related fear.
Research questions: What effect does ICBT compared to SC have on a) the level of childbirth
related fear b) a request for cesarean section c) compliance and satisfaction with treatment.
Design: A randomized controlled trial of women reporting childbirth related fear during
pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of
given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after
birth. Intervention: The intervention will focus on management of childbirth related fear.
This means that the participants do weekly sessions and homework assignments during
pregnancy.
Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.
Secondary outcomes are level of childbirth related fear at 2 months and one year after birth,
preferences for mode of birth, request for elective cesarean section, compliance and
satisfaction with treatment and costs.
Expected benefits: This study will contribute to the development of new treatment methods for
childbirth related fear. Evidence of the best treatment to reduce childbirth related fear
based on the results from this study could be implemented in clinical practice and hopefully
decreases the numbers of cesarean sections without medical indications.
Description:
Project area
Childbirth related fear is a public health issue strongly related to subsequent reproduction
and women's and children's health. It could be assumed that previous negative birth
experiences are caused by interventions and/or lack of support from staff during birth which
in turn could be linked to women's emotional wellbeing. Childbirth related fear often
involves a request for a caesarean section, which in turn could have short and long term
consequences for women's and children's health. The majority of studies on childbirth related
fear have focused on maternal characteristics and the reasons for childbirth fear. Fewer
studies have addressed treatment options for curing childbirth fear. Standard care for women
with childbirth related fear in Sweden, is usually counseling with midwives and sometimes
this counseling leads to an elective caesarean section. In general, women are satisfied with
counselling. However, research shows no major effect of counselling, neither in decreased
numbers of cesarean sections on maternal request nor in decreased levels of childbirth
related fear one year after birth. Today a substantial financial amount of the budget for
women's health care is allocated to treatment of childbirth fear using counselling teams. The
introduction of such counseling teams was introduced without being preceded by any randomized
trials about its effects. In other areas of health care, cognitive behavior therapy is
recommended for psychosocial issues. The present project will compare Internet based
cognitive behavior therapy (iCBT) with standard care (SC).
Survey of the field Childbirth related fear has gained major research interest particularly
in the Scandinavian countries.Severe fear of childbirth has been reported to 6-10% in a
Finish study, and fear comparable to PTSD 1.3%. Measures of childbirth related fear: The FOBS
scale was developed in a cross-cultural comparative study where two VAS scales (measuring
worries and fears in relation to childbirth) were combined.
Reported reasons for fear of childbirth are; fear of pain, childhood abuse, and feelings that
the woman or the baby will be damaged during birth or even die, being denied help from
caregivers or felt badly treated by delivery staff and, for multiparous women previous
emergency caesarean sections or previous negative experiences of birth.
Treatment for childbirth fear Most Swedish hospitals have special counseling teams for women
with childbirth fear, often called Aurora groups. Their antenatal midwife refers women to
these special teams. The most common treatment model for these women are visits with a
specially trained midwife, but psycho-somatic support, cognitive behavior therapy, and
relaxation techniques are also used. This counseling treatment in Sweden has not been
preceded by large randomized studies, but studies indicate that women are satisfied with the
treatment. It has also been shown that women who are referred to the Aurora services more
frequently have caesarean sections.
Aim and research questions The aim of this study is to compare Internet given cognitive
behavior therapy (ICBT) with standard care (SC) for pregnant women identified with childbirth
related fear.
Research questions: What effect does Internet given cognitive behavior therapy compare to
standard care have on a) the level of childbirth related fear b) request for cesarean section
c) compliance and satisfaction with care and d) costs for the treatment?
Method
Design: A randomized controlled trial of women with childbirth related fear. One arm will
receive standard care and one arm cognitive behavioral therapy by internet.
Setting: One large Swedish university hospital and two regional hospitals. Recruitment: All
pregnant women at the routine ultrasound screening examination, offered to all pregnant women
during gestational week 16-20, will receive oral and written information about the study. The
recruitment process will follow two steps. First, all women who attend the ultrasound
examination will be handed a leaflet where a few questions are asked about their age, parity,
gestational week, access to Internet and the FOBS-scale. The women will receive a brief
information text with information about the purpose of the study, e.g. that we are interested
in women's feelings towards the approaching birth and if they score over the cutoff point
will be offered to attend a study of treatment for childbirth fear. To be eligible for
inclusion, potential participants have to meet the following criteria; a) Swedish speaking b)
scoring ≥60 on the FOBS score c) available internet access.
In the second step of recruitment, women who score 60 or above on the FOBS-scale will be sent
a letter of invitation and a phone call from the recruiting midwives. The invitation letter
and the phone call will explain the study outline and the women will be informed that they
will be randomized either to iCBT or standard care. Informed consent from the women will be
returned either by an on-line form to the U-CARE platform or in a prepaid envelope indicating
consent or not. The women will be provided with login details to the U-CARE platform and all
communication thereafter will be though the platform regardless of which arm women will be
randomized to. After completion of a baseline questionnaire randomization to treatment will
occur and women will receive instructions about the following program. If randomized to the
iCBT arm the psychologist will introduce the iCBT-treatment by a telephone call.
Intervention: Internet Cognitive behavioral therapy (iCBT) is given by a psychologist by the
U-CARE platform. The intervention will focus on management of childbirth related fear. This
means that the participants read texts and do homework assignments instructed from an
internet page. Additional resources such as pictures, animations, videos and sounds will be a
part of the treatment program. A psychologist will communicate with the participants through
internal text-messages and feed back on their homework assignments.The therapist will devote
time to each participant each week via the Internet. The content of the intervention will be
standard components from CBT, for example relaxation training, behavioral activation,
exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment. The
women complete homework assignments, this consists of tasks such as doing relaxation
training, to perform planned new behaviors, to break behavioral habits, to expose oneself to
frightening situations or to change sleeping routines.
Standard care: Counselling for childbirth fear is given by the antenatal care midwife and by
specially trained midwives working in collaboration with obstetricians at approximately 3-5
face to face counselling sessions. Often a visit to the delivery unit is included in the
program.
Measures: At baseline previously validated instruments measuring women's levels of fear of
childbirth, anxiety, depressive symptoms, stressful life events, Prenatal Attachment
Inventory (PAI-R), Blood and injection phobia, Cambridge Worry Scale, Performance Based
Self-esteem, and Pain Catastrophizing scale.
In addition to the instruments included, women's socio-demographic and obstetrics background,
psychosocial history, experience of childbirth, attitudes towards birth, partner and family
support will be measured along with the woman's previous birth preferences.
Follow up: The randomized women will receive follow up questionnaires at 30 and 36 weeks of
pregnancy where women's fears and emotional wellbeing will be further investigated using the
above mentioned instruments. Two months and one year after birth additional questions about
birth outcome, birth experience, breast feeding duration, attachment and bonding to their
infant and their satisfaction and experience of the treatment program.
Outcome measures: The primary outcome will be level of childbirth related fear at 36 weeks
gestation. Secondary outcomes are childbirth related fear at two months and one year after
birth, preferences for mode of birth, request for cesarean section in late pregnancy and in
case of a subsequent pregnancy, compliance and satisfaction with the treatment, birth outcome
and costs.
Power analysis: A previous Swedish study showed that 59% of women with childbirth fear during
pregnancy were 'cured' after a year. A power calculation based on a 20% reduction in
childbirth fear, a two-sided test, a power of 0.80 and a level of significance of 5 %, shows
that approximately 200 women need to be enrolled in the study.
Ethical considerations: The study has received full ethical review and approval. The hospital
managers at the participating sites are cooperating with the study. The project leaders' name
and contact details are available in the letter of invitation and women as well as recruiting
midwives are encouraged to make contact if they have questions about the project. All data
collection will be administered by the U-CARE platform and the research group.
Justification: Fear of childbirth is a public health issue strongly related to subsequent
reproduction and women's and children's health. Currently identification and treatment is
taking place without a clear evidence base. It is therefore important to find the most
effective and acceptable treatment for this issue which can be offered to the maximum number
of affected women in the most cost effective and sustainable manner. The study is linked to
new innovations in person centered care in clinical practice using Internet based technology
which is offering new and equitable access to best practice health care.
Expected benefits: This study will contribute to the development of new treatment methods for
childbirth related fear. Finding evidence of the best treatment to reduce childbirth related
fear based on the results from this study could be implemented in clinical practice and
hopefully reduces the psychological distress felt by women during the childbearing period and
reduces the number of caesarean sections requested by women without medical indications.
Consumer perspective and disseminating of study results: Prior to the recruitment of study
participants think-aloud interviews with approximately 30 women will be performed in order to
test the included instruments. In the pilot study women will carefully answer all questions
and at the same time communicate their thoughts to a researcher when completing the
questions, for construct and face validity.
