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Trial withdrawn due to COVID-19.
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| Name | Class |
|---|---|
| Addis Continental Institute of Public Health | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| Boston Children's Hospital | OTHER |
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The ENAT study will test the impact of packages of antenatal interventions to enhance maternal nutrition and manage pregnancy infections on the outcomes of infant birth size, gestational length, and infant growth in the first 6 months of life. Approximately 5,280 pregnant women will be enrolled into the study from 12 health centers in the Amhara region of Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health centers will be randomized to additionally provide a nutritional intervention including daily multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished women. Women across all 12 health centers will be individually randomized to receive one of three infection management interventions in pregnancy: 1) enhanced infection management package (screening-treatment for urinary tract infections and sexually transmitted infections, presumptive deworming); 2) presumptive azithromycin (2g at <24 wks and a second dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed until 6 months postpartum. Outcomes of interest include birth size (weight, length), gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial resistance, and infant size at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine care: Placebo | Placebo Comparator | In all pregnancies presenting at all centers, routine antenatal care will be strengthened:
Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. |
|
| Routine care: Azithromycin | Experimental | Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. |
|
| Routine care: Enhanced Infection Management Package (EIMP) | Experimental | At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrhea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment. |
|
| Enhanced Nutrition Package (ENP): Placebo | Experimental | Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin 500 mg | Drug | Azithromycin 500mg (Kern Pharma): 2g (4 tablets) at 2 time points during pregnancy: enrollment (<=24 weeks gestation), and follow-up ANC at least 4 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Mean infant weight (g) among live born infants measured <72 hour of delivery | Within 72 hours of birth |
| Birth length | Mean infant length (cm) among live born infants measured <72 hours of delivery | Within 72 hours of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age | Mean gestational age at delivery | Birth |
| Preterm birth | Proportion of pregnancies resulting in spontaneous birth <37 weeks gestation among all births |
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Inclusion Criteria:
Exclusion Criteria:
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| Beth Israel Deaconess Medical Center |
| OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Amhara Public Health Institute | UNKNOWN |
| Jhpiego | OTHER |
2x3 factorial randomized controlled trial, with cluster randomization of nutrition interventions and individually randomized infection management interventions
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Masking of Azithro vs. Placebo arm only
|
| ENP: Azithromycin | Experimental | Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. |
|
| ENP: EIMP | Experimental | Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrohea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment. |
|
| Multiple Micronutrient or Fortified Balanced Energy Protein Supplement | Dietary Supplement | Daily multiple micronutrient (MMN) tablet (Contract Pharmacal Corp) for women with mid-upper arm circumference (MUAC) >=23 cm, OR Daily fortified balanced energy protein (BEP) supplement (DSM South Africa; Faffa Food Products): Fortified corn-soy blend (784 kcal/day) for women with MUAC <23 cm |
|
| Placebo oral tablet 500 mg | Drug | Placebo 500mg (Idifarma): 2g (4 tablets) at 2 time points during pregnancy; enrollment (<24 weeks gestation), and follow up ANC at least 4 weeks later |
|
| Enhanced Infection Management Package (EIMP) | Other | ENROLLMENT VISIT: Screening for bacteriuria with urine culture, and antimicrobial susceptibility testing; Screening for chlamydia and gonorrhea with Cepheid GeneXpert; Presumptive deworming with albendazole 500mg. FOLLOWUP TREATMENT VISIT: For women with identified urinary tract infection or asymptomatic bacteriuria, treatment with antibiotics based on antimicrobial susceptibility patterns. For women with identified chlamydia or gonorrhea, treatment of woman (and partner) with appropriate antibiotics. Test of cure sample and retreatment of infection. Second deworming with albendazole at least 4 weeks after enrollment ANC visit. |
|
| Birth |
| Small-for-gestational age (SGA) | Proportions of newborns born SGA (<10% birthweight for gestational age and sex) among live born infants whose birthweight if measured within 72 hours of delivery. | within 72 hours of birth |
| Low birthweight | Proportion of newborns born with weight <2500 g among liveborn infants whose weight is measured within 72 hours of delivery | within 72 hours of birth |
| Length-for-age | Mean Length-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006) | Birth, 6 months |
| Weight-for-age | Mean Weight-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006) | Birth, 6 months |
| Rate of weight gain in pregnancy | Maternal weight gain (kg) per week gestation in the 2nd and 3rd trimester | From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months |
| Maternal anemia | Mean hemoglobin concentration | Third trimester antenatal care visit (28-40 weeks gestation) |
| Stillbirth | Rate of stillbirths per 1000 births | Birth |
| Prevalence of nasopharyngeal macrolide resistance in mothers-infants | Prevalence of nasopharyngeal macrolide resistance among S. pneumoniae isolates in mothers-infants at 1 and 6 months postpartum | 1 and 6 months post-partum |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D044342 | Malnutrition |
| D012749 | Sexually Transmitted Diseases |
| D014552 | Urinary Tract Infections |
| D003141 | Communicable Diseases |
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D016870 | Neisseriaceae Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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