Status:
UNKNOWN
Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial
Lead Sponsor:
Vital Pakistan Trust
Collaborating Sponsors:
Aga Khan University
Conditions:
Undernutrition
Eligibility:
FEMALE
13-49 years
Phase:
NA
Brief Summary
This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin...
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 o...
Eligibility Criteria
Inclusion
- 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
- Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
- Having known food allergies if reported by woman (like peanut, lentils)
Key Trial Info
Start Date :
July 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
1884 Patients enrolled
Trial Details
Trial ID
NCT04012177
Start Date
July 22 2019
End Date
December 31 2023
Last Update
October 13 2022
Active Locations (1)
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1
Peri-urban slum (Rehri Goth)
Karachi, Sindh, Pakistan