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| Name | Class |
|---|---|
| The Children's Investment Fund Foundation | OTHER |
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Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ready-to-use supplementary food + anti-infective bundle | Experimental | The women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34 |
|
| Corn-soy-blend | Active Comparator | The women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready-to-use-supplementary food | Dietary Supplement | Specially formulated supplementary food for pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant birth length | mean birth length of infants born to mothers in the study | up to 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal weight gain | Average weekly weight gain of women in the study | up to 40 weeks |
| Proportion recovered from maternal malnutrition | proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm |
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Inclusion Criteria:
Exclusion Criteria:
Must be pregnant woman
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, MD | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Moriba Street | Pujehun | Pujehun District | Sierra Leone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36475019 | Derived | Hendrixson DT, Lasowski PN, Koroma AS, Manary MJ. Newborn Mid-Upper Arm Circumference Identifies Low-Birth Weight and Vulnerable Infants: A Secondary Analysis. Curr Dev Nutr. 2022 Sep 12;6(10):nzac138. doi: 10.1093/cdn/nzac138. eCollection 2022 Oct. | |
| 34582451 | Derived | Hendrixson DT, Smith K, Lasowski P, Callaghan-Gillespie M, Weber J, Papathakis P, Iversen PO, Koroma AS, Manary MJ. A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial. PLoS Med. 2021 Sep 28;18(9):e1003618. doi: 10.1371/journal.pmed.1003618. eCollection 2021 Sep. |
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| Corn-soy-blend | Dietary Supplement | Standard of care for malnutrition in pregnancy in Sierra Leone |
|
| Monthly intermittent preventive treatment of malaria during pregnancy (IPTp) | Drug | Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later. |
|
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| Standard intermittent preventive treatment of malaria during pregnancy (IPTp) | Drug | Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg). |
|
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| Insecticide-treated mosquito net | Other | An insecticide-treated mosquito net at the time of enrollment into the study. |
|
| Azithromycin | Drug | Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation. |
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| Albendazole | Drug | Single dose albendazole 400mg given in the second trimester. |
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| Bacterial vaginosis testing and treatment | Combination Product | Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days. |
|
| up to 40 weeks |
| Premature delivery | proportion of infants born prematurely | up to 36 weeks |
| Newborn head circumference | mean head circumference of infants born to women in the study | up to 40 weeks |
| Infant birth weight | mean birth weights of infants born to mothers in the study | up to 40 weeks |
| Infant weight at 6 weeks, 3 and 6 months | infant ponderal growth | up to 6 months |
| Infant length at 6 weeks, 3 and 6 months | infant linear growth | up to 6 months |
| Infant survival at 3 and 6 months | survival of infants in the study | up to 6 months |
| 32153879 | Derived | Hendrixson DT, Koroma AS, Callaghan-Gillespie M, Weber J, Papathakis P, Manary MJ. Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial. BMC Nutr. 2018 Apr 2;4:15. doi: 10.1186/s40795-018-0218-y. eCollection 2018. |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D057148 | Insecticide-Treated Bednets |
| D017963 | Azithromycin |
| D015766 | Albendazole |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D057147 | Mosquito Nets |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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