Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vital Pakistan Trust
• Collaborator: Aga Khan University
• Treatments: Azithromycin; Choline; Niacin; Niacinamide; Nicotinic Acids

Criteria

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)