The PromisE
Package
Prevention of Mortality and Infant Stunting
PROMISe improves the outcomes of malnourished pregnant women and their newborns in Sierra Leone and Malawi with a community-based package of nutrition, mental health, and anti-infection interventions
Malnutrition During Pregnancy
CAUSES
Immediate causes
-
Inadequate dietary intake
-
Disease
-
Pregnancy (increase nutrient requirements and more susceptible to disease )
Underlying Causes
-
Inadequate food availability (seasonality, geography, cost)​
-
Inadequate/poor access to healthcare and social support (psycho-social support, health services, prenatal care, water/sanitation)
-
Societal Status (education, age at marriage/pregnancy, gender equality)
In sub-Saharan Africa women are...
pregnant women in sub-Saharan Africa are malnourished, at risk of suffering pregnancy complications and adverse birth outcomes associated with their nutritional status
more likely to die from childbirth than women in high-income countries
and their babies are...
more likely to die in their first month of life than babies born to mothers in high-income countries
CONSEQUENCES
Significant risk factor for adverse maternal outcomes
-
Life-threatening hemorrhage
-
Sepsis
-
Hypertensive disorders of pregnancy
-
All-cause mortality
Significant risk factor for adverse fetal outcomes
-
Infant mortality
-
IUGR
-
Low birth weight
-
Pre-term delivery
-
childhood mortality
-
stunting
-
acute infections
-
Long-term impaired cognitive outcomes
WHY It MATTERS...
When mothers survive
COMMUNITIES THRIVE
Women help build stronger families, this results in thriving communities with less poverty and more productive economies.
WINDOW
OF OPPORTUNITY
Healthy babies start with healthy mothers
Optimizing intrauterine & postnatal growth
RANDOMIZED CONTROLLED CLINICAL EFFECTIVENESS TRIAL
COMPREHENSIVE INTERVENTION
-
A novel ready-to-use supplementary food (RUSF)
-
Albendazole in 2nd trimester
-
Enhanced intermittent preventative treatment for malaria (IPTp)-SP every 4 weeks & insecticide treated bed net
-
Azithromycin 2x (beginning 2nd trimester & 3rd trimester)
-
Testing & treatment for bacterial vaginosis
STANDARD OF CARE
-
Blended corn/ soy flour
-
Iron & folic acid supplementation
-
Albendazole in 2nd trimester
-
Intermittent preventative treatment for malaria (IPTp) (3 doses of SP during 2nd and 3rd trimester)
STUDY POPULATION
-
​1514 pregnant women
-
<35 weeks of gestation by fundal height
-
Moderate or severe malnutrition
-
Defined by MUAC ≤23 cm
-
-
Planning to reside in the study area
-
Attending 1 of the 43 antenatal clinic sites in Western Rural Area and Pujehun districts in Sierra Leone
PRIMARY OUTCOMES
-
Infant birth length and weight
SECONDARY OUTCOMES
-
Maternal: weekly maternal weight gain and recovery from malnutrition
-
Infant: Length, weight, HC, MUAC, and survival through 6 months of life
Beleuman Welbodi
The belly women-Well body Study in Sierra Leone
a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone
PARTICIPATION
The study was conducting in conjunction with government provide antenatal care
At enrollment, demographic info, time of last menses, estimated date of delivery were recorded, a clinical symptom questionnaire was completed and weight, height, MUAC, blood pressure, and fundal height were measured by trained study staff
Participants returned for follow-up every two weeks for anthropometric assessment and provision of the study foods and medications until delivery
Birth measurements were taken as soon as was feasible
​
Follow-up occurred at 6 weeks, at 3 months and at 6 months after birth (Infant survival, weight, length, head circumference, MUAC, morbidity, & feeding practices as well as maternal weight, MUAC and morbidity were assessed at these visits)
IMPACT
MATERNAL OUTCOMES
-
Intervention group gained more weight​
-
Intervention group had larger MUAC
-
Fewer women in the intervention group (77.3%) compared to standard of care (87.8%) delivered with fundal height less than 37 cm
-
The intervention group had a 7.2% higher rate of recovery from wasting
INFANT OUTCOMES
Infant born to the intervention group mothers were...
0.3 cm longer
Infant born to the intervention group mothers weighed...
49 grams more
The first 28 days of life – the neonatal period – is the most vulnerable time for a child’s survival
Neonatal Mortality Rate
Standard of care neonatal mortality rate is...
Intervention neonatal mortality rate
Demonstrates the survival curve for infant mortality from birth until 6 months of life by treatment group
What's in the package?
Daily ration of a ready-to-use peanut-based paste food supplement
-
balanced energy-protein
-
micronutrient-fortified
-
optimized for local ingredients
-
essential polyunsaturated fatty acids to prevent and treat perinatal mood disorders and reduce premature delivery
Azithromycin
-
antibiotic for the treatment of placental infections
Albendazole
-
antiparasitic agent
Sulfadoxine-pyrimethamine (monthly)
-
antimalarial agent
Insecticide-treated bed net
Screening and treatment of perinatal depression and anxiety
THE PROMISE PACKAGE
Our recent groundbreaking research with the Beleuman Welbodi demonstrated that addressing both inflammation and inadequate dietary intake results in ...
better maternal weight gain
longer, heavier and stronger newborns
more than 50% reduction in newborn mortality
but a gap in the Beleuman Welbodi package was something that demands attention.....
Maternal Mental Health
80% treatment gap for perinatal mental health disorders
25% of women in low-and middle- income countries experience perinatal mental health disorders
poses significant and lasting implications for mother's health and quality of life and is associated with adverse development in newborns and children
WHERE?
Sierra Leone
Malawi
The PROMISe Package will roll out in selected districts in Malawi and Sierra Leone
KEYs TO SUCCESS
-
implemented within existing healthcare system
-
community-based at all levels of the project
-
efficient supply chain
-
extensive monitoring and evaluation plan with built in adaptation
IMPACT
A growth trajectory to last a lifetime
