- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012177
Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial (MumtaPW)
Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women to Improve Birth Outcomes in the Peri-urban Slums of Karachi, Pakistan -a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Maternal under nutrition has a critical role in etiology of poor perinatal outcomes like low birth weight (LBW), accounting for 60-80% of all neonatal deaths and impacting nearly 20 million newborns overall. In Pakistan, nearly half of the households are food insecure with or without hunger. Great disparities exist between urban-rural and within urban disadvantaged populations living in the poorest of slums. In Sindh province alone, 72% of households are food insecure and 50% are with moderate to severe hunger. Around 18% of the married woman of reproductive age in Pakistan, are underweight and deficient of different micronutrients for example, 42% and 41% of women are Vitamin A and Zinc deficient, respectively.. This impacts childhood stunting, wasting, and underweight, prevalence of which, among under-five children is around 44%, 15% and 31%, respectively in Pakistan. WHO antenatal care (ANC) guidelines recommend the use of fortified balanced energy-protein supplements during pregnancy, but there is a lack of guidance on the best product/supplement for use in a particular setting. Until recently, the WHO ANC guidelines has made no recommendations on the use of these supplements in food insecure and undernourished settings. This is an area that required further research. Additionally, there is emerging literature on use of Choline and Nicotinamide during pregnancy and its potential additional impact on birth outcomes including growth and development after prenatal supplementation with Choline and Nicotinamide.
Apart from nutrition supplement, the prophylaxis use of antibiotics, especially AZM is also under strong debate, as many studies have shown improvements in birth outcomes in low middle income settings. The possible mechanism of AZM may be explained through reduction in the risk of maternal infections during pregnancy. A systematic review showed that prophylaxis may reduce the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women With no effect on birth outcome but there were several biases reported such as high loss to follow-ups and limited numbers of included studies.. Therefore, robust evidence is needed via a field trial in the local context to evaluate the efficacy and effectiveness of the locally-produced, balanced energy-protein supplement alone or in combination with prophylaxis dose of AZM or balanced energy-protein supplement alone or in combination with Choline and Nicotinamide to pregnant woman on maternal and birth outcomes in low-income and food insecure settings. This could help to draw inferences for larger public health policy-making. This investment is specifically aiming to look at what impact a newly formulated nutritional supplement for pregnant and lactating women (PLW) can have on improving birth outcomes and as well as its potential to reduce wasting, stunting and underweight in infants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindh
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Karachi, Sindh, Pakistan
- Peri-urban slum (Rehri Goth)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gestational age between ≥8 and < 19 weeks confirmed by ultrasound
- Able to give written voluntary informed consent.
- Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance.
- Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome.
- Singleton and viable fetus on ultrasound
- Not working woman, and available for ANC and compliance visits at home.
- Previously not enrolled in pregnant woman trial.
- Previously not enrolled in Lactating woman trials.
Exclusion Criteria:
- Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
- Having known food allergies if reported by woman (like peanut, lentils)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control Arm
Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard)
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Experimental: Nutrition only Arm
Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard)
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Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
Other Names:
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Experimental: Nutrition plus Azithromycin Arm
Arm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard).
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Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
Other Names:
Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.
Other Names:
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Experimental: Nutrition plus Choline and Nicotinamide Arm
Arm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard).
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Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
Other Names:
Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.
Other Names:
Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome
Other Names:
Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Birth weight of newborn
Time Frame: To be assessed within 72 hours of birth
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Weight of the newborn assess in gram to assess the difference among four arms
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To be assessed within 72 hours of birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birth length of newborn
Time Frame: To be assessed within 72 hours of birth
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Length of the newborn assess in cm to assess the difference among four arms
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To be assessed within 72 hours of birth
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal hemoglobin
Time Frame: At enrollment and 32 weeks of pregnancy
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Assessed in (gm/dl) through Hemocue for all who are agree to assess the difference among four arms
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At enrollment and 32 weeks of pregnancy
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Maternal Ferritin level
Time Frame: At enrollment and 32 weeks of pregnancy
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To assess the difference among four arms (ng/ml)
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At enrollment and 32 weeks of pregnancy
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Maternal Vitamin D level
Time Frame: At enrolment and 32 weeks of pregnancy
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To assess the difference among four arms (ng/ml)
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At enrolment and 32 weeks of pregnancy
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Cord blood
Time Frame: At birth
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Sub-sample - 50 live births in each arm to assess the difference in term of micro- and macro-nutrients and antibodies status.
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At birth
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Plasma for proteomic analysis
Time Frame: At week 19 and 32 of pregnancy
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Sub-sample - 50 women in each arm to gain in-depth analysis of proteome which potentially impact (if any) by administration of Azithromycin
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At week 19 and 32 of pregnancy
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Plasma for Niacin metabolites
Time Frame: At enrolment and 32 weeks of pregnancy
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Sub-sample - 50 women in each arm to assess the comparison among difference arm to see how these level of metabolites are different among four arm compared to those who received extra daily dose.
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At enrolment and 32 weeks of pregnancy
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Urine for Choline metabolites
Time Frame: At enrolment and 32 weeks of pregnancy
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Sub-sample - 50 women in each arm to see how these level of metabolites are different among four arm compared to those who received extra daily dose.
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At enrolment and 32 weeks of pregnancy
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Magnetic resonance imaging (MRI) of infants (post birth outcomes)
Time Frame: 6 and 12 months of infant's age
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Sub-sample - 50 infants of mothers each arm who will have their birth outcomes to assess brain morphology and volume of infants, using portable MRI machine "Hyperfine".
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6 and 12 months of infant's age
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Global Scale for Early Development assessment
Time Frame: 6 and 12 months of infant's age
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Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using Global Scale for Early Development (GSED)' tool.
Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age.
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6 and 12 months of infant's age
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Mullen assessment
Time Frame: 6 and 12 months of infant's age
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Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using 'Mullen' tool.
Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age.
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6 and 12 months of infant's age
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Hammersmith Neurological Examinations
Time Frame: 6 and 12 months of infant's age
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Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using 'Hammersmith Neurological Examinations (HINE)' tool.
Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age.
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6 and 12 months of infant's age
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Maternal depression
Time Frame: At week 19 and 32 of pregnancy and then at 6 and 12 month post-partum
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Maternal depression will be assessed using Patient Health Questionnaire (PHQ-9) during antenatal period and postnatal period.
Depression scarring will be comparing scoring between the arm.
Further, we will assess and compare depression severity (in any) from 'None minimal' (0-4 score) to 'Severe' (20-27 score)
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At week 19 and 32 of pregnancy and then at 6 and 12 month post-partum
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Maternal and infant stool microbiome
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared for stool microbiome
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Maternal and infant stool Lipocalin-2
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared Lipocalin-2 (ng/gm)
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Maternal and infant stool Carlprotectin
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared Carlprotectin (ug/gm)
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Maternal and infant stool Myeloperoxidase (MPO)
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared Myeloperoxidase (ng/ml*dilution factor)
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Maternal and infant stool TaqMan assay
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared different colonies
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Maternal and infant stool Bifido species
Time Frame: At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm to assess and compared for Bifido species
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At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Metabolomic work - Maternal during pregnancy
Time Frame: At enrolment and 32 week of pregnancy
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All women who are agreed in each arm, for metabolomic work using 'Volumetric Absorptive Microsampling (VAM)
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At enrolment and 32 week of pregnancy
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Metabolomic work - Mother-Infant dyad
Time Frame: 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Sub-sample - 50 women and the infant in each arm for metabolomic work using 'Volumetric Absorptive Microsampling (VAM) Infants - sub-sample of 50 infants of same enrolled women in each arm for metabolomic work using'Volumetric Absorptive Microsampling (VAM)
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1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
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Human milk oligosaccharides
Time Frame: within 72 hours of birth
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Sub-sample - 50 women in each arm to assess and compare breastmilk oligosaccharides
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within 72 hours of birth
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Breastmilk quality
Time Frame: within 72 hours of birth
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Sub-sample - 50 women in each arm to assess and compare breastmilk quality (macro-and micro-nutrients)
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within 72 hours of birth
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Breastmilk microbiome
Time Frame: within 72 hours of birth
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Sub-sample - 50 women in each arm to assess and compare microbiomes.
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within 72 hours of birth
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Breastmilk immunoglobulin
Time Frame: within 72 hours of birth
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Sub-sample - 50 women in each arm to assess immunoglobulins in the breastmilk
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within 72 hours of birth
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yasir Shafiq, MSc, Vital Pakistan Trust
- Principal Investigator: Ameer Muhammad, MSc, Vital Pakistan Trust
- Principal Investigator: Fyezah Jehan, MSc, Aga Khan University
- Principal Investigator: Muhammad Imran Nisar, MSc, Aga Khan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Malnutrition
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Anti-Infective Agents
- Antimetabolites
- Gastrointestinal Agents
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Vitamins
- Vitamin B Complex
- Nootropic Agents
- Lipotropic Agents
- Choline
- Nicotinic Acids
- Azithromycin
- Niacinamide
- Niacin
Other Study ID Numbers
- 004-VPT-IRB-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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