Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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 (AZM) prophylaxis (two prophylaxis oral doses) versus in
combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and
Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon
after birth (approximately within 72 hours). This is an open label, community-based,
randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome
assessor will be blinded. The comparison groups are control arm (only routine ANC care and
nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus
Choline and Nicotinamide arm.