Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Authors

Ameer Muhammad, VITAL Pakistan Trust, Karachi,
Zoha Zahid Fazal, Aga Khan UniversityFollow
Benazir Baloch, Aga Khan UniversityFollow
Muhammad Imran Nisar, Aga Khan UniversityFollow
Fyezah Jehan, Agha Khan UniversityFollow
Yasir Shafiq, VITAL Pakistan Trust, Karachi,

Document Type

Article

Department

Medical College Pakistan

Abstract

Background: Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment, and childhood undernutrition necessitate the supplementation of fortified balanced energy protein (BEP) during pregnancy in low-income settings especially with scarce literature available in this subject. Hence, this paper extensively covers the protocol of such a trial conducted in an urban slum of Karachi, Pakistan.
Methods: The trial is community-based, open-labelled, four-arm, and randomized controlled that will include parallel group assignments with a 1:1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. All pregnant women (PW), if identified between > 8 and < 19 weeks of gestation based on ultrasound, will be offered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus BEP supplement plus 2 doses azithromycin (intervention arm 2), or (4) ANC counseling plus BEP supplement plus daily single dose of nicotinamide and choline (intervention arm 3).
Trial registration: ClinicalTrials.gov NCT04012177 . Registered on July 9, 2019.

Comments

Pagination are not provided by the author/publisher

Publication (Name of Journal)

Trials

Recommended Citation

Muhammad, A., Fazal, Z. Z., Baloch, B., Nisar, M. I., Jehan, F., Shafiq, Y. (2022). Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial). Trials, 23(1).
Available at: https://ecommons.aku.edu/pakistan_fhs_mc_mc/243

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