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)

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 2 - 13
• Main Authors: Muhammad, Ameer, Fazal, Zoha Zahid, Baloch, Benazir, Nisar, Imran, Jehan, Fyezah, Shafiq, Yasir
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 03.01.2022; BioMed Central; BMC
• Subjects: Antibiotics; Azithromycin; Azithromycin - therapeutic use; Birth weight; Consent; Dietary supplements; Disease prevention; Dosage and administration; Drug therapy; Enrollments; Female; Fetuses; Food and nutrition; Gestational age; Humans; Hypothesis testing; Infant, Newborn; Intervention; Malnutrition; Mortality; Nutritional Support; Pakistan; Poverty Areas; Pregnancy; Pregnancy Outcome; Pregnant Women; Prenatal care; Proteins; Randomized Controlled Trials as Topic; Study Protocol; Surveillance; Testing; Ultrasonic imaging; Womens health; Pakistan; Karachi Pakistan
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05960-9

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. 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). ClinicalTrials.gov NCT04012177 . Registered on July 9, 2019.