Iron Deficiency Anemia Clinical Trial
Official title:
Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if: 1. Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population. 2. Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population. Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
Status | Recruiting |
Enrollment | 5500 |
Est. completion date | September 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: Intervention arm: All pregnant women in their first or second trimester, who are enrolled in Benazir Nashonuma Program (BNP). Non-intervention arm: All pregnant women in their first or second trimester, who are not enrolled in Benazir Nashonuma Program (BNP). Exclusion Criteria: - Women who intend to migrate or relocate for more than 3 months during the study period will be excluded from the study. - Women in the non intervention group who are consuming specialized nutritious food (SNF) from any source at the time of enrollment will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan Office | Dadu | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | Bill and Melinda Gates Foundation, International Food Policy Research Institute, London School of Hygiene and Tropical Medicine |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of low birthweight | Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery | Within 48-hours of delivery | |
Primary | Prevalence of stunting | Height-for-age =-2 SD of the WHO Child growth standards median | At 6 months of age | |
Primary | Prevalence of stunting | Height-for-age =-2 SD of the WHO Child growth standards median | At 12 months of age | |
Secondary | Prevalence of wasting | Weight-for-height =-2 SD of the WHO Child growth standards median. | At 6 and 12 months of age | |
Secondary | Prevalence of Iron deficiency anemia in pregnant women | Hemoglobin levels below 11 g/dl, serum ferritin less than or equal to 30 ng/ml, mean corpuscular volume MCV below 95 fl will be considered diagnostic of iron deficiency anemia | At 9th month on pregnancy | |
Secondary | Prevalence of Iron deficiency anemia in infants | Hemoglobin concentration of less than 11.0 g/dl and ferritin levels of less than 15 micrograms/L | 2 point times: At 6 and 12 months of age | |
Secondary | Number of antenatal care (ANC) visits during pregnancy | Attending at least 8 ANC consultations in a health facility/clinic | At delivery | |
Secondary | Number of women who had an Institutional delivery | Having delivered in a health facility | At delivery | |
Secondary | Number of women who had Skilled birth attendance | Birth attended by a skilled health personnel | At delivery | |
Secondary | Number of women who had Postnatal care (PNC) check ups | Receiving a postnatal health check while in a facility or at home within 6-weeks of postnatal period | 3 months after delivery | |
Secondary | Mean nutrient intake of energy in kilocalories of the pregnant woman | Mean nutrient intake of energy in kilocalories using 24-hour recall. | At 9th month of pregnancy | |
Secondary | Prevalence of infants who were ever breastfed | Number of infants who were breastfed at least once | At 12 months of age | |
Secondary | Prevalence of infants who had early initiation of breastfeeding | Number of infants who were put to the breast within one hour of birth | At 12 months of age | |
Secondary | Prevalence of infants who were exclusively breastfed | Number of of infants aged 0-5 months who were fed exclusively with breast milk during the previous day | At 12 months of age | |
Secondary | Prevalence of infants who consumed a minimum acceptable diet | Number of infants 6-12 months of age who consumed a minimum acceptable diet during the previous day | At 12 months of age | |
Secondary | Prevalence of infants with minimum dietary diversity | Number of infants 6-12 months of age who consumed foods and beverages from at least four out of eight defined food groups during the previous day | At 12 months of age | |
Secondary | Mean scores of Neurodevelopmental outcomes of the infant | Neurodevelopmental outcomes of the children will be assessed using Bayley Scales of Infant and Toddler Development (BSID-IV). Mean scores will be reported for cognitive, language and motor development of the infant using Bayley's scales. Higher scores in the Bayley Scales indicate better outcomes | At 12 months of age | |
Secondary | Number of women consuming specialized nutritious food (SNF) | Utilization of supplementation (SNF) by the woman during pregnancy and first 6 months of lactation after delivery | At 6 months after delivery | |
Secondary | Number of infants consuming specialized nutritious food (SNF) | Utilization of supplementation (SNF) by the infant from 6-23 months of age | At 12 months of age |
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