Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06323759 |
| Other study ID # |
2022-14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Université Sorbonne Paris Nord |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has
become a global public health goal. However, there is a disparity in the prevalence of
breastfeeding (BF) in different regions of the world. According to French perinatal surveys,
the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure
remains stable according to the last perinatal survey in 2021, it decreases sharply, to
34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see
an action plan or an education intervention for women and couples aimed at promoting BF.
However, women's needs to educate about BF and the need for professionals to reflect on their
practices are highlighted by numerous perinatal surveys. It should be noted that despite the
importance given to the promotion of BF found in all National Nutrition and Health Programs,
none of them provide pedagogical means or an education program to achieve the objectives set.
At present, in France, there is no breastfeeding education program and professionals
accompany women by implementing experimental actions without considering the complexity of
the promotional dimension (producing a behavioral change) and the educational dimension
(understanding the pedagogy of the proposed actions)
Description:
The benefits of exclusive breastfeeding for infants and mothers are widely recognized by the
scientific community.
As a result, its promotion has become a global public health goal: 75% of newborns should be
breastfed by 2030. According to the World Health Organization (WHO), the global average for
exclusive breastfeeding has increased from 14% in 1985 to 37% in 2015. The WHO report also
notes a disparity in the prevalence of exclusive breastfeeding at birth and at six months of
age.
According to the National Health Nutrition Programs and the recommendations of Public Health
France and the French Society of Pediatrics, the promotion of exclusive breastfeeding remains
the main preventive measure to combat health inequalities from childhood to ensure healthy
and equitable development. They emphasize the education of mothers and/or couples, providing
women with "know-how to act" by acquiring knowledge, developing management skills, and
building self-confidence and motivation. However, these plans set quantified objectives, but
do not propose educational actions or interventions to promote BF, and even less indicate the
means for professionals to achieve these objectives.
In France, couples and/or women can, if they wish, benefit from birth and parenting
preparation sessions offered by midwives in the prenatal period. One of these sessions is
dedicated to encouraging and educating pregnant women to breastfeed. In the postnatal period,
despite an increase in the number of staff trained to support breastfeeding mothers, more
than 84% of couples are referred to breastfeeding support networks outside the maternity unit
(PMI, private midwives, associations). Even the practice of early discharge (stay < 2 days)
for low-risk women has inevitably reduced the time spent by hospital staff in educating
women. At present, this activity is outsourced and carried out by private midwives, who carry
out between 2 and 3 early postnatal follow-up consultations to assess the mother's and
newborn's needs on a medical, psycho-educational level. These consultations are not mandatory
but are strongly recommended.
Further scientific research:
A scoping review of international publications carried out in 2020 made it possible to draw a
map of the pedagogical methods practiced, to identify some of their characteristics favoring
the initiation and duration of BF, and to demonstrate that professionals rarely refer to a
pedagogical strategy and conditions favorable to learning to ensure a better promotion of BF.
The areas for improvement identified can be considered in order to better adapt educational
strategies in terms of their pedagogical design. In addition to this literature review, a
multicenter and prospective survey will be carried out among breastfeeding women and hospital
midwives who led the childbirth preparation sessions to identify, on the one hand, the
educational needs of breastfeeding women and, on the other hand, the educational strategies
proposed by caregivers to promote BF. This study has been approved by the Ethics Committee of
the Sorbonne University N°CER-2021-119 and is registered in the ClinicalTrials.gov registry:
NCT05271812.
The survey highlights that, overall, the educational needs expressed by breastfeeding women
and the educational approaches taken by midwives correlate with the educational
characteristics identified in the Scope Review. Midwives' pedagogical attitudes as well as
the educational strategies they propose seem to have an impact on the reinforcement of the
decision to breastfeed and the continuation of this decision in the longer term. The
perceived usefulness of the educational session is expressed in the reinforcement of the
motivation to breastfeed, the development of self-esteem and the feeling of self-management
(competence to manage their breastfeeding). We also identified the pedagogical
characteristics of the educational sessions offered by midwives. Thus, this review of the
literature, coupled with the survey of women's educational strategies and needs, has allowed
us to draw up pedagogical guidelines that can be built around a more adapted engineering to
promote BF.
Based on the results of the scoping review and the primary study, we modeled an educational
intervention based on a strategy, including favorable conditions, to promote breastfeeding.
The research question is therefore: Can an adapted educational intervention based on an
educational strategy and conducive learning conditions improve the promotion of
breastfeeding? Theoretical framework: This research focuses on the pedagogical dimension and,
more specifically, on improving the pedagogical engineering of current educational
interventions (in the context of antenatal and postnatal follow-up of women) and their
contribution to the maintenance of breastfeeding from the point of view of women and
professionals.
This is a systemic approach based on evaluations of therapeutic education programs. It allows
for a more comprehensive and different approach to biomedical and clinical research that
attempts to demonstrate the effectiveness of a program or intervention in BF promoting
without explaining the didactics of the programs.
The evaluation framework of this model is based on critical realism. It is proposed by
Greenhalgh, Harvey and Walshe and explained in the RAMESES II reporting standards for realist
evaluations. Numerous publications, by Ridde.V and Robert.E, confirm the relevance of the
pragmatic approach, which allows researchers to explain what works in a program, for what
reasons and in what contexts. It makes it possible to establish an explanatory theory for a
program model, according to the contexts that influence it and the mechanisms that hinder
effects. Bearing in mind that these operations are not linear and that the expected effects
(results) may be different depending on the conditions of time, place, individuals
themselves, social, cultural, political, and economic organizations. It is a multi-center,
comparative, mixed-methods study with a comprehensive approach. Realistic evaluation shows
what works and what does not work in a program, and how and to what effect. It enables the
construction of an explanatory theory in terms of contexts of influence, generative
mechanisms, and effects produced in the BF ecosystem.
This is a sequential and explanatory mixed-methods study (QUANTI-Quali). Quantitative data
will be analyzed using R software, while qualitative data analysis will be conducted using
Atlas-Ti software.
