The aim of this reseach project is to gain insights into the effects of distribution and intermission of postpartum care hours on the success rate of breastfeeding and the experienced empowerment and quality of care by the mother during and after…
ID
Source
Brief title
Condition
- Postpartum and puerperal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary study outcome is successful breastfeeding (purely breastfeeding, no
supplements) on day 1 after birth and at the end of the postpartum care period.
Successful breastfeeding is considered as the most optimal surrogate outcome
measure for health benefits of mother and newborn in the short and long term.
Meta-analyses show that breastfeeding could protect children against health
infections, increases childs' intelligence and possibly reduces chances of
obesity and diabetes. Furthermore, breastfeeding could also protect women
against breast cancer and ovarian cancer and diabetes type 2. It is even said
that worldwide breastfeeding initiatives can reduces thousands of deaths among
children under 5years and prevent thousands of deaths due to breastcancer among
women.
SOURCE:
Victoria CG, Bahl R, Barros AJD, França GVA, Horton S, Krasevec J, Murch S,
Sankar MJ, Walker N, Rollins NC, for the Lancet Breastfeeding Series Group.
Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong
effect. Lancet. 2016; 387: 475-90.
Secondary outcome
- Experienced empowerment by the mother after childbed, based on the Maternal
Empowerment Questionnaire (MEQ), which is part of the CLiK questionnaire and
will be completed 4 weeks after childbirth. This questionnaire measures the
empowerment of mothers.
- Experienced quality of postpartum care by mother, also based on CLiK
questionnaire, which is completed four weeks after childbirth. We will
specifically look at the evaluation questions / items related to postpartum
care service (i.e. 5 items: general experience of postpartum care service,
amount of hours received, experience health status today, experience of the
maternity care assistant in the family and clients' choice for this specific
postpartum care organisation).
- Successful breasfeeding (no supplements) at 4 weeks after birth; around 4
weeks mother will have her visit to the youth care.
- Experience with the intervention by clients and caregiver who accompanied and
was medically responsible for parturition and childbed (e.g. midwife),
postpartum care consultant, postpartum caregiver, lactation consultant and
youth caregiver: focus on the barriers and possibilities of intervention.
- Cost-effectiveness of the intervention: based on the actual postpartum care
hours and healthcare needs of client after postpartum care period until first
visit to JGZ (youth care).
- Additional outcomes registred in the national Perinatale Registratie NL will
be used in terms of the interventions' safety, like: complications, readmission
and mortality mother/child during childbed (up to 28 days after birth).
SOURCE:
Factsheet CLiK (CLient Informatie Kraamzorg) en MEQ (Maternal Empowerment
Questionnaire). Academische Werkplaats Kraamzorg in Geboortezorg, 2017.
Background summary
The Dutch maternity care model with home-based postpartum care is unique. This
uniqueness results in little to no scientific knowledge on the effectiveness
and efficiency of home-based postpartum care. Filling the knowledge gap and
following the trend of personalized care are prerequisites in preserving this
form of maternity care. Therefore this study researches the possibility of
flexible distribution and intermission of postpartum care hours. It concerns a
practice-based innovative research model which, without extension of postpartum
hours, analyses whether distribution and intermission of postpartum care hours
benefits the health of mother and child.
It is expected that this planning flexibility of postpartum care hours will
have a positive effect on the success rate of breastfeeding and improve the
experienced empowerment and quality of care by mothers (and their partners).
Furthermore we hope to realise a better and more efficient cooperation between
different health institutes and a smoother start for youth care organisations.
Scientific evidence of essential and effective postpartum care can contribute
to an improved maternity care system and its goal to give all mothers and
newborns a perfect kick-off of life. To a greater extent, this new generated
knowlegde can reduce maternal and perinatal mortality and morbidity in the long
run.
Study objective
The aim of this reseach project is to gain insights into the effects of
distribution and intermission of postpartum care hours on the success rate of
breastfeeding and the experienced empowerment and quality of care by the mother
during and after childbed.
This intervention concerns the planning of postpartum care hours rather than
the number of hours. The amount of postpartum care hours will always be
restricted by the guidelines of the currently used LIP (as it is now) in order
to make no additional medical expenses. However, it might be possible that
distrbution and intermission of postpartum care hours limit medical costs.
Furthermore, a prerequisite for the planning of hours is continuation of care.
In order to achieve abovementioned goals, the following questions are asked:
1. What effect has flexible distribution and intermission of (indicated)
postpartum care hours on the success rate of breastfeeding, experienced
empowerment and quality of care by the mother during and after childbed?
2. How do the client, responsible caregiver (who accompanies and is responsible
during parturition and childbed) and postpartum caregiver experience the
flexibility in planning postpartum care hours without the restriction of 8-10
consecutive days?
3. What effect has flexibility in planning of postpartum care hours on the
actual used hours and the related cost of postpartum care?
Study design
Randomised controlled trial, randomisation on level of individual client.
Intervention
Intervention group:
Clients are offered the opportunity for flexible planning of their postpartum
care hours (i.e. distribution and/or intermission), without making any
additional health care costs. This means that the indicated 24-49 postpartum
care hours may be distributed throughout the whole day and on noncontiguous
days (to a maximum of 14 days). Additional indicated postpartum care (up to
80hrs) may also be distributed throughout the whole day and noncontiguous days
(to a maximum of 14 days).
Furthermore, a decrease of the number of postpartum care hours is also
possible. In this case, the guarantee of continuity of care is a vital
condition.
(Re)distribution of postpartum care hours is always done in consultation with
the client, the healthcare provider (who accompanies and is medically
responsible during parturition and childbed) and postpartum caregiver; in a
similar manner as is done in the current situation using the LIP.
Control group:
Clients receive the current package of postpartum care hours (i.e. 24-49 hours
in 8 continguous days), possibly followed by an additional indication of hours
(up to 80hrs) within 10 contiguous days (i.e. 2 extra days).
SOURCE:
Landelijk Indicatieprotocol Kraamzorg. Instrument voor toekenning van
kraamzorg: Partusassistentie en kraamzorg geurdende de kraamperiode. BTN,
Z-org, STING, ZN en KNOV, 2008.
Study burden and risks
In our view, the risks of participation are negligible. Possible risks may only
occur to those participants in the intervention group who receive less
postpartum care hours per day than usually (i.e. since they prefer a longer
postpartum care period instead of the amount of hours per day, e.g., 14 days x
3.5h). In that case one can think of potential risk factors like: higher change
of falling or a delay in signaling (health) problems. We would like to
emphasize that these risks are always taken into consideration by the health
care providers when postpartum care hourse are (re)distributed.
The participation burden is considered minimal. The amount of postpartum care
hours is always aligned with the statutory criteria (as indicated by the LIP);
this accounts for both groups (intervention as well control). Besides the
possibility for participants in the intervention group to a broader
distribution and/or intermission of postpartum care hours (they always have the
freedom to choose the 'regular' package), all participants are asked to fill
out a questionnaire (ReproQ), to answer questions during brief phone interview
(on self-reliance) and voluntary participation in focus group discussions (on
self-reliance).
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
pregnant women who have the intention (in week 30 of pregnancy, i.e. intake by postpartum care organisation) to breastfeed, who receive maternal care in the region of Nijmegen and who do not have an additional postpartum care insurance package (for example IZZ Zorg voor de Zorg + Extra 2/3)
Exclusion criteria
pregnant women who do not have the intention (in week 30 of pregnancy, i.e. intake by postpartum care organisation) to breastfeed OR who do not receive maternal care in the region of Nijmegen OR who have an additional postparum care Insurance package (for example IZZ Zorg voor de Zorg + Extra 2/3)
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 | NL61474.091.17 |
| OMON | NL-OMON25085 |