Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.
Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.
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DOI：
10.1093/jn/nxac171
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发表时间：
2022-10-06
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贫血和次优妊娠期体重增加（GWG）与不良的孕产妇和出生结局相关。有限的研究表明，平衡的能量-蛋白质（BEP）补充剂可以降低GWG不足的发生率。我们评估了微量营养素强化的BEP补充剂与铁-叶酸（IFA）片剂相比对贫血、GWG、GWG率和GWG的次要结局的有效性，与医学研究所（IOM）的建议有关。我们在布基纳法索进行了一项随机对照试验，在妊娠<21周的孕妇（15-40岁）中招募。妇女接受BEP和IFA（干预）或IFA（对照）。血红蛋白（g/dL）浓度在基线和第三次产前护理访视（ANC）时测量，而母体体重在基线和所有随后的107周ANC时测量。GWG（kg）计算为女性末次体重测量值（妊娠36周）减去入组时的体重，而GWG率（kg/wk）为GWG除以首次和末次体重测量之间的时间。GWG充足性（%）计算为GWG除以IOM的建议。二元结局包括GWG严重不足、不足和过多。统计分析遵循意向治疗原则。线性回归和概率模型分别适用于连续和二元结局，并根据基线测量值进行调整。BEP组的女性GWG倾向于更高，但无显著差异（0.28 kg; 95% CI：-0.05，0.58 kg; P = 0.099）。此外，在产前贫血患病率、GWG率、GWG充足率、GWG不足或过多的发生率方面没有显著差异。结果对于模型调整和完整病例以及符合方案分析具有稳健性。本试验没有提供证据表明，与IFA相比，强化的BEP补充剂减少了母体贫血或增加了GWG。结合小，但积极的影响，产妇的BEP补充对出生结果，我们的研究结果值得调查额外的生化和产后结果。本试验在clinicaltrials.gov上注册为NCT 03533712。
Anemia and suboptimal gestational weight gain (GWG) are associated with adverse maternal and birth outcomes. Limited research indicates that balanced energy-protein (BEP) supplements reduce the incidence of inadequate GWG. We assessed the efficacy of a micronutrient-fortified BEP supplement on the secondary outcomes of anemia, GWG, GWG rate, and GWG in relation to the Institute of Medicine (IOM)’s recommendations, as compared with an iron–folic acid (IFA) tablet. We conducted a randomized controlled trial in Burkina Faso, among pregnant women (15–40 y old) enrolled at <21 weeks of gestation. Women received either BEP and IFA (intervention) or IFA (control). Hemoglobin (g/dL) concentrations were measured at baseline and the third antenatal care visit (ANC), whereas maternal weight was measured at baseline and all subsequent ∼7-weekly ANCs. GWG (kg) was calculated as a woman's last weight measurement (at ∼36 weeks of gestation) minus weight at enrollment, whereas GWG rate (kg/wk) was GWG divided by the time between the first and last weight measurements. GWG adequacy (%) was computed as GWG divided by the IOM's recommendation. Binary outcomes included severely inadequate, inadequate, and excessive GWG. Statistical analyses followed the intention-to-treat principle. Linear regression and probability models were fitted for the continuous and binary outcomes, respectively, adjusting for baseline measurements. Women in the BEP group tended to have higher, but nonsignificantly different, GWG (0.28 kg; 95% CI: −0.05, 0.58 kg; P = 0.099). Furthermore, there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or incidence of inadequate or excessive GWG. Findings were robust to model adjustments and complete case and per protocol analyses. This trial does not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG, as compared with IFA. In conjunction with the small, but positive, effects of maternal BEP supplementation on birth outcomes, our findings warrant the investigation of additional biochemical and postnatal outcomes. This trial was registered at clinicaltrials.gov as NCT03533712.