Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium
Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium.
BMJ Open. 2021 Mar 24;11(3):e038393. doi: 10.1136/bmjopen-2020-038393.
Adequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for-gestational-age newborns. There is a probable positive effect of providing pregnant women a balanced energy-protein (BEP) food supplement, but more evidence is needed. The MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III project aims to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy and lactation in rural Burkina Faso. This paper describes the study protocol.
MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Houndé. Eligible pregnant women, aged between 15 and 40 years old and living in the study areas, will be enrolled. Women will be randomly assigned to one of the four study groups: (1) prenatal intervention only, (2) postnatal intervention only, (3) prenatal and postnatal intervention or (4) no prenatal or postnatal intervention. The intervention group will receive the BEP supplement and iron/folic acid (IFA) tablets, while the control group will only receive the IFA tablets following the national health protocol. Consumption will be supervised by trained village women on a daily basis by means of home visits. The primary outcomes are small-for-gestational age at birth and length-for-age z-score at 6 months of age. Secondary outcomes will be measured at birth and during the first 6 months of the infants' life. Women will be enrolled from October 2019 until the total sample size is reached.
MISAME-III has been reviewed and approved by the University Hospital of Ghent and the ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained. Results will be published in relevant journals and shared with other researchers and public health institutions.
NCT03533712.
孕期营养充足对母婴都至关重要。母体营养不良可能导致胎儿死亡，或导致早产和小于胎龄儿等不良分娩结局。为孕妇提供均衡的能量-蛋白质（BEP）补充食品可能会产生积极影响，但还需要更多证据。“母婴健康微量营养素项目（MISAME）III 项目”旨在通过在布基纳法索农村地区的孕期和哺乳期测试 BEP 补充剂来改善分娩结局和婴儿生长。本文介绍了研究方案。
MISAME-III 是一项在胡恩德区六个农村卫生中心集水区实施的四组个体随机疗效试验。符合条件的孕妇，年龄在 15 至 40 岁之间，居住在研究地区，将被纳入研究。妇女将被随机分配到以下四个研究组之一：（1）仅产前干预，（2）仅产后干预，（3）产前和产后干预，或（4）无产前或产后干预。干预组将接受 BEP 补充剂和铁/叶酸（IFA）片剂，而对照组将按照国家卫生方案仅接受 IFA 片剂。通过家访，每天由受过培训的乡村妇女监督摄入量。主要结局是出生时小于胎龄和 6 个月时的年龄别身长 Z 评分。次要结局将在出生时和婴儿生命的头 6 个月进行测量。从 2019 年 10 月开始招募妇女，直到达到总样本量。
MISAME-III 已由根特大学医院和布基纳法索 Centre Muraz 伦理委员会审查和批准。将获得知情同意。研究结果将发表在相关期刊上，并与其他研究人员和公共卫生机构共享。
NCT03533712。
