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Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial

(2021) BMJ OPEN. 11(3).
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Abstract
Introduction: 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 SAnte de la Mere 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. Methods and analysis: MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Hounde. 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. Ethics and dissemination: 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.
Keywords
General Medicine, nutrition, community child health, protocols & guidelines

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MLA
Vanslambrouck, Katrien, et al. “Effect of Balanced Energy-Protein Supplementation during Pregnancy and Lactation on Birth Outcomes and Infant Growth in Rural Burkina Faso: Study Protocol for a Randomised Controlled Trial.” BMJ OPEN, vol. 11, no. 3, 2021, doi:10.1136/bmjopen-2020-038393.
APA
Vanslambrouck, K., de Kok, B., Toe, L. C., De Cock, N., Ouedraogo, M., Dailey-Chwalibóg, T., … Kolsteren, P. (2021). Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJ OPEN, 11(3). https://doi.org/10.1136/bmjopen-2020-038393
Chicago author-date
Vanslambrouck, Katrien, Brenda de Kok, Laeticia Celine Toe, Nathalie De Cock, Moctar Ouedraogo, Trenton Dailey-Chwalibóg, Giles Hanley-Cook, et al. 2021. “Effect of Balanced Energy-Protein Supplementation during Pregnancy and Lactation on Birth Outcomes and Infant Growth in Rural Burkina Faso: Study Protocol for a Randomised Controlled Trial.” BMJ OPEN 11 (3). https://doi.org/10.1136/bmjopen-2020-038393.
Chicago author-date (all authors)
Vanslambrouck, Katrien, Brenda de Kok, Laeticia Celine Toe, Nathalie De Cock, Moctar Ouedraogo, Trenton Dailey-Chwalibóg, Giles Hanley-Cook, Rasmané Ganaba, Carl Lachat, Lieven Huybregts, and Patrick Kolsteren. 2021. “Effect of Balanced Energy-Protein Supplementation during Pregnancy and Lactation on Birth Outcomes and Infant Growth in Rural Burkina Faso: Study Protocol for a Randomised Controlled Trial.” BMJ OPEN 11 (3). doi:10.1136/bmjopen-2020-038393.
Vancouver
1.
Vanslambrouck K, de Kok B, Toe LC, De Cock N, Ouedraogo M, Dailey-Chwalibóg T, et al. Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJ OPEN. 2021;11(3).
IEEE
[1]
K. Vanslambrouck et al., “Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial,” BMJ OPEN, vol. 11, no. 3, 2021.
@article{8701278,
  abstract     = {{Introduction: 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 SAnte de la Mere 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.

Methods and analysis: MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Hounde. 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.

Ethics and dissemination: 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.}},
  articleno    = {{e038393}},
  author       = {{Vanslambrouck, Katrien and de Kok, Brenda and Toe, Laeticia Celine and De Cock, Nathalie and Ouedraogo, Moctar and Dailey-Chwalibóg, Trenton and Hanley-Cook, Giles and Ganaba, Rasmané and Lachat, Carl and Huybregts, Lieven and Kolsteren, Patrick}},
  issn         = {{2044-6055}},
  journal      = {{BMJ OPEN}},
  keywords     = {{General Medicine,nutrition,community child health,protocols & guidelines}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{10}},
  title        = {{Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2020-038393}},
  volume       = {{11}},
  year         = {{2021}},
}

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