Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial
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.
Timeline
- Start
- 2019-07-22
- Primary completion
- 2022-09-05
- Completion
- 2023-12-31
Publications
- Pasha A, Khan S, Qazi MF, Balouch B, Qamar JB, Nisar MI, Jehan F. Impact of Prenatal Nutrition Interventions on Infant Longitudinal Growth: A Secondary Analysis of the Mumta Pregnant Women Trial in Pakistan. Mayo Clin Proc Innov Qual Outcomes. 2026 Jun 30;10(4):100727. doi: 10.1016/j.mayocpiqo.2026.100727. eCollection 2026 Aug.
- Muhammad A, Fazal ZZ, Baloch B, Nisar I, Jehan F, Shafiq Y. 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. 2022 Jan 3;23(1):2. doi: 10.1186/s13063-021-05960-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 2000 mg | Oral |
| Subject | Choline Bitartrate | Small molecule | 450 mg | Oral |
| Subject | Nicotinamide | Other / unclassified | 100 mg | Oral |