To evaluate the effect of CP in the Dutch setting on psychosocial- and health outcomes (concerning the pregnancy) and the success of implementation of CP (including a costanalysis)
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infant morbidity, composite outcome: APGAR score <7 5 minutes postpartum or
admission to the neonatal intensive care unit.
Secondary outcome
Prenatal care satisfaction
Proportion of initiating breastfeeding
Other study parameters:
1) Perinatal health indicators:
- Infant data (GA at delivery, birth weight, APGAR score, hospital admission,
mortality)
- Maternal data (blood pressure, weight, weight change during/after pregnancy,
health behaviors, psychosocial outcomes (stress, coping, depression) and social
support, birth preparation, self-efficacy, health literacy).
- Care data (mode of birth, place of birth)
2) Process evaluations:
- Pregnant women: adequacy of care, care use, participation of partners, uptake
interventions, perceived integration of care, satisfaction, attendance of group
sessions.
- Health professionals: degree of implementation, provided
information/activities to women during care, collaboration / integration with
partners, alterations made to the CP-program, satisfaction with provided care,
costs.
Background summary
In the Netherlands, the perinatal mortality and morbidity rate is relatively
high, compared to surrounding countries. Pregnancy outcones are especiaaly
worse for women with a low socio-economic background or for immigrants. Women
could benefit greatly if we could lower the risk factors for perinatal
mortality (a.o. pretem birth and low birth weight). Furthermore, we aim to
optimalize the experience of pregnancy and child birth for women. This can be
achieved by centering the pregnant woman within the provided care. A possible
solution herefore, and for lowering the risk of perinatal mortality, is the
approach of CenteringPregnancy, a different model of prenatal care.
CP in the US is primarily focused on immigrant and non-immigrant women with a
low soci-economic background. Scientific research within this population shows
that this type of care has a positive effect on health literacy and behavior,
such as more prenatal and postnatal knowledge, better preparedness for delivery
and higher breastfeeding percentages. Furthermore, women experience more social
support, and are more satisfied with prenatal care. Women with higher
stress-rates at the beginning of the pregnancy show a significant raise in
selfesteem, significant less stress, and significant less social problems or
depression postpartum. Having followed CP, women's risk for perinatal morbidity
is lower than with individual care: 33% lower risk for preterm birth (in a high
risk group), higher birth weight, end less sub-standard care. Despite these
positive results, a more systematic approach is needed to support the effect op
CP.
In 2011-2012 a feasibility study was performed in the Netherlands, in
collaboration with three midwifery practices. In September 2012, already 160
women received prenatal care according to the CP program. The results of this
study are promising. Pregnant women and their midwives are enthousiastic about
CP. Women rate the care with an 8.4 on average on a scale 0-10. Further results
are currently being analysed, but the feasibility of CP in the Netherlands is
very plausible. This is an important fact, since the important differences in
obstetrical systems between the Netherlands and the countries where CP was
introduced so far (US, Canada, UK, Australia, Sweden).
Study objective
To evaluate the effect of CP in the Dutch setting on psychosocial- and health
outcomes (concerning the pregnancy) and the success of implementation of CP
(including a costanalysis)
Study design
Randomised clustered trial, with a stepped wedge design. Participating clusters
will be randomized to the moment they implement CP, the intervention. During
the controlperiod of a cluster (the months between the start of the study and
the start of implementation), control data will be collected. After
implementing CP, the clusters collect intervention data, untill the end of the
study period.
Intervention
In stead of the usual individual prenatal check-ups, prenatal care is provided
in ten sessions for a group of women. During a session, the physical check is
combined with education, interactive educational methods and conversation on
what is important to women during their pregnancy. Groups consist of 8-12 women
with the same gestational age. They get to know each others through the
sessions and are stimulated to play a greater role in their own care process.
This is achieved by interactive educational methods, theme sessions, a handbook
wtih personal goals en reflection on these goals. Furthermore, women are
actively involved in their medical care, by measuring their blood pressure and
weighing, filling in their own pregnancy file. Sessions are supervised by a
medically responsible care provider (midwife, gynaecologist), and an assistant.
Study burden and risks
Control period: women receive usual individual care, participants are asked to
fill out questionnaires at four time points.
Intervention period: identical to control period, additionally women can choose
at their intake for further individual prenatal care of group prenatal care
according to CP.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- < 24 weeks of gestational
- able to communicate in Dutch or English
- given informed consent
Exclusion criteria
- physically or mentally unable to communicate in a group setting
- > 24 weeks of gestation
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL44319.058.13 |
OMON | NL-OMON27178 |