Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05271812 |
| Other study ID # |
APHP210925 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Mehrnoosh Yazdanbakhsh |
| Phone |
(0)140274507 |
| Email |
mehrnoosh.yazdanbakhsh[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Background The long-term benefits of breastfeeding for newborns and mothers are undeniable
and scientifically recognized. Current WHO/UNICEF guidelines suggest increasing exclusive
breastfeeding to 75.0% by 2030 worldwide. However, there is substantial heterogeneity in
breastfeeding practices around the world. Because while breastfeeding promotion is complex,
breastfeeding instructions remain without any educational design in general.
Primary Objective:
- Determine the effectiveness of breastfeeding educations among the nursing mothers during
first month after childbirth.
Secondary objectives:
- Identify the theoretical and pedagogical engineering framework the breastfeeding
educations proposed in antenatal among nursing mothers and professionals.
- Assess the perceived usefulness of nursing mothers regarding to the educational
interventions for breastfeeding management and its frequently complications.
- Assess the perceived usefulness of professionals, regarding to the pedagogical
engineering of educational interventions offered to nursing mothers.
- Assess women's competency regarding to the educational interventions for breastfeeding
management and its frequently complications.
- Evaluate the organization of educational interventions proposed by professionals.
Method & Results:
The results will be obtained by calculating the mean, standard deviation, median and
interquartile range. The Chi-square and Yates' uncorrected and corrected tests will be
applied for comparison calculation.
Evaluating criteria for feeling of usefulness and breastfeeding competency will be studied
using Likert's four level model, 10-Point numerical scales and short answer questions. The
relationships between these variables will be studied by using a sequential mixed method
combining interpretative, comprehensive, and explanatory approach.
Description:
Promoting breastfeeding, a global public health issue The benefits of exclusive breastfeeding
are widely recognized by the scientific community for infants and their mothers. Moreover,
its promotion has become a global public health target. According to the World Health
Organization (WHO), the global average of exclusive breastfeeding (EBF) has increased from
14% in 1985, to 37% in 2015. The WHO report also notes a disparity about EBF prevalence at
birth and at six months.
Guidelines and global positioning to promote breastfeeding WHOs' and UNICEFs' Objective
proposed in 2030, 75% of newborns should be exclusively breastfed. This represents 10 million
children in the world.
Several measures are recommended: professional commitment, training couples to breastfeed,
early and close accompaniment of mothers in breastfeeding initiation and its supporting. WHO
proposed an accompanying measure through the Baby-Friendly Hospital Initiative (BFHI) label.
This label can be revised every five years.
In France, most maternity are not labelled BFHI. Due a lack of means and human resources.
According to the last European commission of the Baby-Friendly Hospital Initiative (BFHI) in
December 2019, only 46 maternity out of 498 in France, excluding the military health service,
are labeled.
Also, WHO has emphasized communication with Couples, health care breastfeeding skills.
French breastfeeding prevalence evolution in relation to its decisive criteria Since 1995,
various surveys in France have shown a clear increase of EBF prevalence at birth. However,
the last perinatal survey conducted in 2016 showed a decrease between 2010 and 2016, from
60.3% to 52.2%, with an average EBF of 15 weeks. These progressions are insufficient compared
to other northern European countries where exclusive breastfeeding rates at maternity
discharge exceed 90%.
Breastfeeding is an individual decision, but many reports incriminate the impact of
socio-economic, cultural, and psychological criteria and their interactions in an ecosystemic
framework in women decision.
Indeed, the "Epifane study" found a correlation between breastfeeding cessation, age, and
lower level of maternal education. The EBF rate among the young mothers with a low
socioeconomic level drops from 54% to 35% as early as the first month after the birth. The
Elfe survey confirmed that the EBF prevalence is higher in older, managerial mothers with a
higher level of maternal education.
Geographical origin is one of the criteria that influence breastfeeding rate at long term.
Indeed, mothers from sub-Saharan Africa, North Africa, Asia, and America breastfeed more
longer.
For mothers in low socioeconomic status, EBF successful is associated with nurturing mother
model, previous experiences, and self-esteem, while for mothers in high socioeconomic status,
EBF successful is associated with medical discourses, her own breastfeeding knowledges, and
self-training.
The domestic tasks between men and women, women investment in her professional careers, and
societal standard are another decisive criterion which produce a heterogeneity of the
breastfeeding practices between mothers.
However, the medical supervision of pregnancy and labor, and status of newborn at birth
influence the breastfed choice. Regarding to Callahan S, a psychologist, sometimes
"over-medicalized" supervision of pregnancies can create a couple dependence state on
caregivers for making decision to breastfeed. This dependence creates a cognitive conflict
that modifies women behaviors and attitudes concerning her birth and breastfeeding objective.
French recommendations and institutional support for breastfeeding According to the National
Nutrition and Health Programs and the French health public recommendations, the breastfeed
promoting remains principal measure to prevent childhood inequalities in health. This
recommendation gives importance to the mothers and couple education. The objective is to
transmit to women "a knowledge to act" with the of breastfeeding knowledge acquisition, the
development of breastfeeding skills, self-confidence, and motivation. These new instructions
are based on "health literacy", a well-developed concept in the field of public health.
WHO has defined this concept as "the personal characteristics and social resources needed by
individuals and communities to access, understand, evaluate and use information and services
to make health decisions. In Europe, 12% of people surveyed have inadequate health literacy
and 35% have limited health literacy according to the Health Literacy Europe (HLS-EU)
results. The level of literacy skills of the French is among the lowest in European
countries.
Balanced newborns diet and infants through an EBF and its promotion are the major guidelines
of National Nutrition and Health Programs in 2018-2022 and in 2019-2023. Thiers objectives
provide for a reinforcement of women accompaniment by perinatal professionals before, during
and after pregnancy and during breastfeeding.
However, these objectives do not propose the educational actions or programs to promoting
breastfeeding. These organisms do not propose guidelines or means for professionals to
achieve these objectives.
BREASTFEEDING PRACTICE AND ITS SUPPORTING Currently, one of the sessions of the Preparation
to Birth and Parenthood (PNP) is dedicated to the practice of breastfeeding. Couples can
benefit, individually or in groups, in the maternity hospital or at home, from a session
dedicated to the practice of breastfeeding.
In the hospital sector, the mapping of the promotion of breastfeeding shows that despite an
increase in the number of staff trained to accompany breastfeeding mothers, more than 84% of
couples are referred to breastfeeding support networks outside the maternity (PMI, private
midwives, associations, networks). Only 32% of Staff declare that they have systematically
provided written and oral information to couples on breastfeeding.
After discharge, women can benefit fallow-up. This consists of two or three postnatal visits
carried out by midwives. It is about making a health supervision, a mother psychological
state and her educational needs. Currently, more than 220,000 women benefit from them, with a
majority of primiparous women (60%), multiparous women with two children (25%) and
multiparous women with three children (13%). The impact of this program on the promotion of
breastfeeding, both in terms of support and in economic impact, has not been studied.
For Women, breastfeed is not a natural practice, and she must be always valued and reassured
in her breastfeeding. The importance of the psychoeducational approach about breastfeeding
are recognized by the professionals. However, breastfeeding education remains empirical, with
a lacks pedagogical engineering. In addition, government recommendation's do not provide
benchmarks for this activity, nor do they propose pedagogical means to achieve these
objectives.
Focus on educational interventions at the international level An international scoping review
was carried out to map the educational interventions used, to identify their pedagogical
characteristics, and to promote the choice, implementation, and breastfeeding duration.
This literature review revealed that many interventions begin in the third trimester of
pregnancy and end in the postnatal period. The teaching strategies are diverse and combined.
An increase breastfeeding duration was noted where the pedagogical objectives aim focused on
developing women's knowledge of lactation and its complications and the correct breastfeeding
positions. The women breastfeed more longer when education methods based on
"socioconstructivist" and cognitivist approaches. Interactive tools have effectively raised
women's awareness of breastfeeding value and its continuation at mid-term. the desire to
breastfeed and its continuation were found when the learning environment and other criteria
such as self-esteem, self-efficacy, and personal motivation were considered by the trainers.
Finally, the quality of the caregivers and their competencies were the essential factors for
breastfeeding continuation at short and mid-term.
This review also allowed us to observe that professionals rarely refer to pedagogical
engineering to guarantee the effectiveness of their educational methods.
DESCRIPTION OF THE ELEMENT(S) OF THE RESEARCH This research is interested in the pedagogical
dimension and more specifically on pedagogical engineering existing in the educational
interventions and its effect on breastfeeding duration at short term.
This research focuses on three elements:
To identified women and professionals' judgments regarding to the educational interventions.
The pedagogical evaluations planned allow to map the education practices and to highlight
their pedagogical characteristics through didactic analysis. This is a needs determination in
pedagogical engineering.
Measuring women and professional's perception of usefulness and their satisfaction levels
could provide additional information to evaluate the perceived usefulness of the educational
interventions.
Finally, women competencies and its components, self-efficacy level and self-esteem level are
the additional criteria to evaluate breastfeeding education impact among the nursing mother.
