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Global Nutrition (Poster Session)

(P24-044-24) The Impact of Enhancing Nutrition and Antenatal Infection Treatment on Birth Outcomes in Amhara, Ethiopia: A Pragmatic Randomized Clinical Effectiveness Study

Monday, July 1, 2024
12:45 PM – 1:45 PM CT
Location: Poster Board 176
Disclosure(s):
Nebiyou Fasil, MPH, PhD: No relevant financial relationship(s) with ineligible companies to disclose.


Objectives: We aimed to determine the impact of antenatal interventions to optimize maternal nutrition and infection management on birth outcomes in Ethiopia.

Methods: We conducted a pragmatic, open-label, 2×2 factorial randomized clinical effectiveness study among pregnant women enrolled ≤ 24 weeks gestation in 12 rural health centers in Amhara, Ethiopia. Eligible health centers were randomized to deliver an enhanced nutrition package (ENP) [iron-folic acid, iodized salt, micronutrient fortified balanced energy protein (BEP) supplement for undernourished women] or routine care. Individual women were randomized to receive an enhanced infection management package (EIMP) [genitourinary tract infection screening-treatment and enhanced deworming] or routine care. The primary outcomes were birth weight and length; secondary outcomes were gestational age, preterm delivery, small-for-gestational-age, low birthweight, stillbirth, newborn length- and weight-for-age z-scores. Analysis was intention-to-treat.

Results: From August 2020 to December 2021, 2399 women were randomized (604 ENP+EIMP, 600 ENP, 593 EIMP, 595 routine care) and followed until June 2022, with 2170 pregnancy outcomes analyzed (565 ENP+EIMP, 549 ENP, 525 EIMP, 531 routine care). In the ENP arm, 427(36%) women were eligible for BEP and consumed on average 74 days. The prevalence of genitourinary tract infection was low(4.9%), while parasitic stool infections were common (31%). There was no difference in birthweight [ENP vs non-ENP: adjusted mean difference -4.0g (-70.9 to 62.9); EIMP vs. non-EIMP: 17.6g (-26.9 to 62.3)] or birth length [ENP: -0.31cm (-0.98 to 0.37); EIMP: 0.16cm (-0.09 to 0.41)] between study arms. In the ENP+EIMP group, the stillbirth rate was lower compared to routine care [7.1/1000 vs. 24.7/1000 births; adjusted relative risk: 0.29 (0.09 to 0.94)]. The packages did not significantly affect other secondary outcomes.

Conclusions: In this pragmatic study implemented within the Ethiopian health system, enhanced nutrition and infection packages did not affect birth weight or length. Stillbirth rates were lower in the group receiving both packages.

Registry: ISRCTN15116516

Funding Sources: Bill and Melinda Gates Foundation