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To assess Nurturing healthy insulin function evidence of Balancec of Nutritional periodization principles balanced protein energy supplementation on pregnancy Dextrose Exercise Fuel, a literature search was suppleement on PubMed, the Cochrane library, and the World Health Organization Regional Databases.
The suplement date of search was February 28, ebergy The Balancef of available reviews energj meta-analyses were also hand searched to look for any additional studies. All randomized and quasi-randomized controlled trials assessing impact of balanced protein energy supplementation on pregnancy outcomes were eligible for inclusion, irrespective of language, geographical region or publication status.
Small for gestational age was defined as a baby whose weight was below the 10 th percentile for its gestational age [ 15 ], while neonatal mortality was defined as death of a live born infant within the first 28 days of life [ 16 ]. Data from all the included studies were double abstracted onto a standardized form for each outcome of interest.
The primary outcomes of interest were small for gestational age babies, mean birth weight and neonatal mortality. We abstracted key variables with regards to the study identifiers and context i.
study population, type and duration of supplementation etcstudy design i. sequence generation, allocation concealment, blinding and attritionsample size and data on primary outcomes. For dichotomous outcomes, the total number of participants for each group and the number of participants experiencing an event was extracted.
For continuous data, means with their standard deviations were abstracted. Each included study was assessed and graded according to the CHERG adaptation of the GRADE criteria [ 1314 ].
In this method of qualitative evaluation, a randomized or a cluster randomized trial was given a high score initially and the grade was subsequently decreased or increased depending on strengths or limitations of study. Reasons for heterogeneity were explored by doing a sensitivity analysis by taking out studies of moderate or low quality.
Fixed models were used for primary analysis. In case of cluster randomized controlled trials, it was taken into account whether the study subjects were randomized in groups i. clusters or at individual level.
Preference was given to cluster adjusted values given in the study and if results were not adjusted for cluster randomization, sample size were adjusted by using an estimate of the intra-cluster correlation co-efficient ICC derived from the trial if possibleor were inferred from similar studies [ 17 ].
Pooled estimates of the evaluated outcome measures were calculated by the generic inverse variance method. This method is a common and simple version of the meta-analysis procedure and is so named because the weight given to each study is chosen to be the inverse of the variance of the effect estimate i.
one over the square of its standard error [ 17 ]. All analyses were conducted using software Review Manager version 5 [ 18 ]. Recommendations for Lives Saved Tool LiST were based on qualitative grading of the overall evidence according to the GRADE criteria and quantitative attributes according to the CHERG guidelines [ 14 ].
The quality grade of overall evidence from all the included studies for each outcome, was assessed on the basis of volume and consistency of the overall evidence, the size of the pooled effect and the strength of the statistical evidence for an association between the intervention and outcome [ 14 ].
We identified titles from searches conducted in all databases Figure 1. After screening the titles and abstracts, 22 studies were identified that addressed protein energy supplementation during pregnancy. Six of these studies were excluded because the only intervention in these studies was dietary advice about increase in protein energy content [ 19 — 24 ].
Two studies were excluded because they addressed high or iso-caloric protein energy supplement [ 2526 ]. Fourteen studies addressed balanced protein energy supplementation during pregnancy [ 27 — 40 ]. Two of these studies were excluded because both the groups received food supplementation high versus low energy [ 3334 ].
Thus a total of eleven studies were included in this review [ 27 — 3235 — 39 ]. Flow diagram showing identification of studies evaluating effect of balanced protein energy supplementation during pregnanancy.
Additional File 1 presents the characteristics of included studies. Five of the included studies were from developing countries [ 2830323641 ] and six were from developed countries [ 27293137 — 39 ]. In seven of the included studies, women were undernourished and were at risk of having a low birth weight baby [ 27 — 30323537 ].
However, the method of assessment of maternal nutrition status and risk of low birth weight was very variable in the included studies. Additional File 2 presents the risk of bias table. Some of the studies were at increased risk of bias for sequence generation and allocation concealment and the grades were adjusted accordingly.
Table 1 reports the overall quality grading of the outcomes and results of the corresponding meta-analyses for outcomes of interest for inclusion in the LiST. There was no heterogeneity in the pooled estimate and all the studies were showing a trend towards reduction. On the basis of volume, consistency and statistical significance, this estimate has been recommended as a proxy for reduction in IUGR for the LiST model.
More details about these recommendations are presented in the discussion section. Effect of balanced protein energy supplementation during pregnancy on risk of small-for-gestational age births.
Three studies also reported the impact of balanced protein energy supplementation during pregnancy on neonatal mortality [ 303741 ]. Data on mean birth weight was available from all the eleven included studies [ 27 — 3235 — 39 ].
Pooled results showed that balanced protein supplemented group gained more weight compared to control [Mean difference This effect was more pronounced in malnourished women compared to adequately nourished women Figure 4. Several reviews have concluded that the adverse birth outcome could be directly related to poor maternal nutritional status [ 9124243 ].
The maternal malnutrition during pregnancy is commonly attributed to inadequate dietary intake during pregnancy or undernutrition at the time of conception [ 8334445 ]. Intrauterine growth restriction represents pathological inhibition of fetal growth and failure of the fetus to attain its growth potential [ 46 ].
IUGR has also been used as a marker to assess complications of pregnancy with considerable impact on long term outcomes [ 3 ].
There is however, no standard definition of IUGR. The term small for gestational age SGAusually defined as having a birth weight below the 10th percentile of an accepted reference standard, is often used as a proxy measure for IUGR [ 47 ].
These two terms are however not synonymous as some SGA infants may merely represent the lower tail of the 'normal' fetal growth distribution, while others who have been affected in utero by an inadequate nutritional milieu or other growth-inhibiting influences may nevertheless have a birth weight that is 'appropriate' for gestational age AGA [ 47 ].
Even though the terms SGA and IUGR are not synonymous, there is correlation between the two and the higher the SGA rate, the greater the likelihood that SGA is a result of IUGR [ 15 ]. Consonant with the cohort model approach first employed in the Lancet series on maternal and child undernutrition [ 48 ], the LiST tool employs a similar approach and uses the effect of various maternal interventions on SGA which is considered as a proxy measure for IUGR and an indirect cause of mortality and morbidity in children [ 14 ].
We recommend this point estimate for reduction in the risk of SGA births for use in the LiST model as effectiveness of balanced protein energy supplementation in reducing IUGR.
All the included the studies were found to be consistent and demonstrated little heterogeneity on meta-analysis Figure 2. Participants in all the included studies for this analysis were undernourished except in the study by Elwood et al [ 31 ].
If we exclude this study, relative risk becomes 0. This means that results for reduction in risk of SGA do not change significantly by excluding this study and can be generalized to undernourished women.
Our results are also comparable with that of previous reviews assessing nutrition interventions during pregnancy [ 8912 ]. Additional research may alter the size of the effect but is not likely to change the inclusion in the model [ 14 ]. The direction and magnitude of effect size for neonatal mortality was similar to that of IUGR however the boundaries of confidence interval included unity.
There was diversity in the type food used for delivery of protein and energy among studies and included chocolate colored liquid supplements, biscuits, milk, sesame cakes, enriched bread and beverages etc.
The control group was either simply observed with no intervention or given mineral and vitamin supplements only. These variations in the supplement used are understandable keeping in mind diversity of study sites and traditional foods used during pregnancy in the particular study area.
Effect of balanced protein energy supplementation seemed more pronounced in malnourished women. Our pooled results for mean change in birth weight showed that malnourished women benefited the most from balanced protein energy supplementation [mean difference
: Balanced energy supplement| Main navigation | What did the researchers do and find? Analyses were conducted using Stata Adherence to IFA tablets during pregnancy was Checklist of information to include when reporting a cluster randomized trial. However, given the nonblinded nature of the study, outcome assessors could have been aware of the study group allocation by asking the mother. Kramer M, Kakuma R. Dr Aamer Imdad did the literature search, data extraction and wrote the manuscript along with Professor Bhutta. |
| Energy Supplements | Energy Balance Gut Connection | A network of trained village-based project workers visited all eligible women at their homes every 5 weeks to identify pregnancy early, by screening for self-reported amenorrhea. By using our website you agree to our Cookie Policy. Geneva: Licence: CC BYNC-SA 3. clusters or at individual level. Pooled estimates of the evaluated outcome measures were calculated by the generic inverse variance method. We previously reported the primary and secondary outcomes at birth [ 25 ]. |
| Acceptability of a balanced energy protein (BEP) supplement for pregnant women in Bangladesh | Br J Obstet Gynaecol. Results Trial flow We identified titles from searches conducted in all databases Figure 1. themes Nutrition and health. Newborn head circumference, thoracic circumference, and MUAC were measured to the nearest 1 mm with a Seca measuring tape. Table 1. All randomized and quasi-randomized controlled trials assessing impact of balanced protein energy supplementation on pregnancy outcomes were eligible for inclusion, irrespective of language, geographical region or publication status. |
| Effect of balanced protein energy supplementation during pregnancy on birth outcomes | Djazayery Energt Regional overview of Protein-rich meals for athletes and child Coenzyme Q and weight loss trends, supplemwnt and outcomes. Consequently, Balancec benefit Protein-rich meals for athletes enerrgy postnatal BEP supplementation might only have become apparent after 6 months with the introduction of nutritionally suboptimal complementary foods. Indian Journal of Medical Research. Subgroup analysis of the efficacy of maternal postnatal BEP supplementation on infant height-for-age z-score at 6 months. Cochrane Database Syst Rev. Iyengar L: Effects of dietary supplements late in pregnancy on the expectant mother and her newborn. Nutritional values of the BEP supplement for pregnant women a. |
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Energy balance explained - get the balance right!Balanced energy supplement -
Methods Our research was reported using the Consolidated Standards of Reporting Trials CONSORT checklist [ 26 ].
Study setting and design The MISAME-III study protocol has been described elsewhere in detail [ 27 ]. Randomization A stratified permuted block randomization schedule was used to assign women to either the intervention or control arms of the pre- and postnatal interventions.
Intervention and procedures The composition and daily dose of the pre- and postnatal BEP intervention supplements were identical; only the duration of supplementation differed. Inclusivity in global research Additional information regarding the ethical, cultural, and scientific considerations specific to inclusivity in global research is included in S1 Supporting Information.
Results Subject characteristics and study follow-up From a total of 2, women assessed for eligibility, 1, women were randomized into either the control or intervention arms of the pre- and postnatal interventions Figs 1 and S1. Download: PPT. Fig 1. Trial flowchart of the MISAME-III study by the postnatal intervention arms.
Table 1. Baseline characteristics of study participants by post- and prenatal intervention arms 1. Linear growth: Length-for-age z-score and stunting Postnatal BEP supplementation during the first 6 months postpartum did not result in a significant improvement in LAZ at the age of 6 months, our primary outcome Table 2.
Fig 2. Table 2. Effect of maternal postnatal BEP supplementation on infant growth and nutritional status at 6 months 1.
Table 3. Effect of maternal prenatal BEP supplementation on infant growth and nutritional status at 6 months 1. Table 4. Four-arm comparison of the effect of BEP supplementation on linear growth at 6 months 1. Secondary outcomes: Infant growth, nutritional status, and morbidity There was no significant effects of the postnatal BEP intervention on the secondary outcomes at 6 months of age, such as WLZ, WAZ, MUAC, head circumference, hemoglobin concentration, and the prevalence rates of wasting, underweight, and anemia Table 2.
Fig 3. Fig 4. Table 5. Effect of maternal postnatal BEP supplementation on infant morbidity during the 6 months postpartum follow-up 1. Table 6. Effect of maternal prenatal BEP supplementation on infant morbidity during the 6 months postpartum follow-up 1. Discussion The MISAME-III trial indicates that modest increments in size at birth, attained from prenatal fortified BEP supplementation, are sustained at 6 months of age in terms of improved linear growth and lower prevalence of stunting.
Supporting information. S1 CONSORT Checklist. CONSORT checklist of the manuscript. s DOC. S1 Table. Nutritional values of the ready-to-use supplementary food for pregnant and lactating women. s DOCX. S2 Table. Breastfeeding and complementary feeding practices by post- and prenatal intervention arms 1.
S3 Table. Effect of prenatal and postnatal BEP supplementation on linear growth in a subsample of infants at 9 and 12 months of follow-up. S4 Table. Effect of maternal postnatal BEP supplementation on infant growth and nutritional status at 6 months complete cases analysis.
S5 Table. Effect of maternal postnatal BEP supplementation on infant growth and nutritional status at 6 months per-protocol analysis. S6 Table. Effect of maternal prenatal BEP supplementation on infant growth and nutritional status at 6 months complete cases analysis. S7 Table. Effect of maternal prenatal BEP supplementation on infant growth and nutritional status at 6 months per-protocol analysis.
S8 Table. Subgroup analysis of the efficacy of maternal postnatal BEP supplementation on infant height-for-age z-score at 6 months. S9 Table.
Subgroup analysis of the efficacy of maternal prenatal BEP supplementation on infant height-for-age z-score at 6 months. S1 Fig. Trial flowchart of the MISAME-III study by the prenatal intervention arms.
S2 Fig. S1 Supporting Information. Inclusivity in global research. S1 Statistical Analysis plan. Statistical analysis plan: Impact of a prenatal and postnatal balanced energy—protein supplement on birth size and postnatal child growth in Burkina Faso.
s PDF. Acknowledgments The authors thank all the women from Boni, Dohoun, Karaba, Dougoumato II, Koumbia, and Kari who participated in the study, the data collection team, and Henri Somé from AFRICSanté.
References 1. UNICEF, WHO, The World Bank. Levels and trends in child malnutrition: key findings of the edition of the joint child malnutrition estimates. Geneva; View Article Google Scholar 2. Dewey KG, Begum K. Long-term consequences of stunting in early life. Matern Child Nutr. Galasso E, Wagstaff A.
The aggregate income losses from childhood stunting and the returns to a nutrition intervention aimed at reducing stunting. Econ Hum Biol. Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, De Onis M, et al.
Maternal and child undernutrition and overweight in low-income and middle-income countries. Victora CG, Christian P, Vidaletti LP, Gatica-Domínguez G, Menon P, Black RE.
Revisiting maternal and child undernutrition in low-income and middle-income countries: variable progress towards an unfinished agenda. Victora CG, de Onis M, Hallal PC, Blössner M, Shrimpton R. Worldwide timing of growth faltering: revisiting implications for interventions.
Report of the Expert Consultation on the Optimal Duration of Exclusive Breastfeeding. Scherbaum V, Srour ML. The Role of Breastfeeding in the Prevention of Childhood Malnutrition.
World Review of Nutrition and Dietetics. Dewey KG, Heinig MJ, Nommsen LA, Lonnerdal B. Maternal Versus Infant Factors Related to Breast Milk Intake and Residual Milk Volume: The DARLING Study. Dror DK, Allen LH. Overview of nutrients in humanmilk.
Adv Nutr. View Article Google Scholar Kim J, Friel J. Lipids and human milk. Lipid Technol. Allen LH. B Vitamins in Breast Milk: Relative Importance of Maternal Status and Intake, and Effects on Infant Status and function.
Engebretsen IMS, Jackson D, Fadnes LT, Nankabirwa V, Diallo AH, Doherty T, et al. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: The cluster-randomised PROMISE EBF trial.
BMC Public Health. Callaghan-Gillespie M, Schaffner AA, Garcia P, Fry J, Eckert R, Malek S, et al. Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.
Am J Clin Nutr. Bliznashka L, Sudfeld CR, Garba S, Guindo O, Soumana I, Adehossi I, et al. Prenatal supplementation with multiple micronutrient supplements or medium-quantity lipid-based nutrient supplements has limited effects on child growth up to 24 months in rural Niger: a secondary analysis of a cluster randomized trial.
Lanou H, Huybregts L, Roberfroid D, Nikièma L, Kouanda S, Van Camp J, et al. Prenatal Nutrient Supplementation and Postnatal Growth in a Developing Nation: An RCT. Krebs NF, Hambidge KM, Westcott JL, Garcés AL, Figueroa L, Tsefu AK, et al. J Pediatr.
Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Peerson JM, Arimond M, et al. Small-quantity, lipid-based nutrient supplements provided to women during pregnancy and 6 mo postpartum and to their infants from 6 mo of age increase the mean attained length of mo-old children in semi-urban Ghana: A randomized controlled trial.
Dewey KG, Mridha MK, Matias SL, Arnold CD, Cummins JR, Khan MSA, et al. Lipid-based nutrient supplementation in the first day improves child growth in Bangladesh: a cluster-randomized effectiveness trial. Ashorn P, Alho L, Ashorn U, Cheung YB, Dewey KG, Gondwe A, et al. Supplementation of maternal diets during pregnancy and for 6 months postpartum and infant diets thereafter with small-quantity lipid-based nutrient supplements does not promote child growth by 18 months of age in rural Malawi: a randomized controlled tria.
J Nutr. Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Knight RJ, et al. Use of Lipid-Based Nutrient Supplements by HIV-Infected Malawian Women during Lactation Has No Effect on Infant Growth from 0 to 24 Weeks. Olney DK, Leroy J, Bliznashka L, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Reduces Child Stunting in Guatemala: A Cluster-Randomized Controlled Intervention Trial.
Galasso E, Weber AM, Stewart CP, Ratsifandrihamanana L, Fernald LCH. Effects of nutritional supplementation and home visiting on growth and development in young children in Madagascar: a cluster-randomised controlled trial.
Lancet Glob Health. Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, et al. Provision of Pre- and Postnatal Nutritional Supplements Generally Did Not Increase or Decrease Common Childhood Illnesses in Bangladesh: A Cluster-Randomized Effectiveness Trial.
de Kok B, Toe LC, Hanley-Cook G, Argaw A, Ouédraogo M, Compaoré A, et al. Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial.
PLoS Med. Schulz KF, Altman DG, Moher D. CONSORT Statement: updated guidelines for reporting parallel group randomised trials. 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. Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibóg T, Ouédraogo M, et al.
Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso. Huybregts LF, Roberfroid DA, Kolsteren PW, Van Camp JH. Dietary behaviour, food and nutrient intake of pregnant women in a rural community in Burkina Faso.
de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouédraogo M, Dailey-Chwalibóg T, et al. Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso. INSD Institute National de la Statistique et de la Demographie.
Burkina Faso Enquete Nutritionnelle Nationale: SMART de Kok B, Moore K, Jones L, Vanslambrouck K, Toe LC, Ouédraogo M, et al. Home consumption of two fortified balanced energy protein supplements by pregnant women in Burkina Faso.
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Your email address will not be published. This site uses Akismet to reduce spam. Learn how your comment data is processed. No Code. Close menu. Shop All Products. Our trial did not collect data on maternal infection during gestation, but if prevalent in this setting, acute or chronic infection may have reduced the efficacy of the BEP supplements provided.
Likewise, acute or chronic infection in the child could have limited the potential benefits from the nutrients received by the fetus during pregnancy.
Second, starting fortified BEP supplementation during early pregnancy alone might not be sufficient to prevent adverse birth outcomes. Our subgroup analyses indicated that the BEP intervention was potentially more efficacious among women who started pregnancy with a better nutritional status; hence, preconception supplementation may confer greater benefits on birth outcomes.
Although the Women First trial found that providing LNS and BEP at least 3 months prior to conception did not yield additional benefits on child linear growth at birth relative to starting BEP supplementation during gestation [ 12 ], compelling evidence remains scarce and supplementation during the preconception period may warrant further exploration.
A major strength of our study was the high acceptability of the fortified BEP supplement, evaluated in a 2-phase formative study [ 21 , 22 ], and strong emphasis on daily observed intake.
Moreover, the daily observed supplementation reduced the possible risk of sharing the supplement with other household members and supported micronutrient adequacy following existing requirements. A cross-sectional dietary intake assessment showed that BEP did not displace energy and nutrient intake from the usual diet [ 42 ].
Hence, we can almost rule out a substitution effect that could have limited the efficacy of the BEP to support fetal growth and reduce SGA. Another strength was the early enrollment of participants, as a result of a monthly visiting schedule at home by trained village-based project workers, who received refresher trainings and close supervision by the MISAME-III field team.
Finally, in almost all cases, birth weight was measured almost immediately after birth. Our study also had some limitations. First, it was impossible to blind mothers or MISAME-III collaborators to the intervention allocation. Although care was taken to blind the study midwives measuring birth anthropometry, we cannot rule out that intervention allocation was unveiled by asking the mother which supplement she received.
Second, it is possible that improvements are not visible through birth anthropometry and maternal biomarkers to demonstrate any micronutrient deficiencies or placental indicators are needed to assess an intermediate effect of the fortified BEP supplement on maternal nutritional status and placental function e.
Ongoing multiomics substudies will provide insight into the biochemical profiles of mother infant dyads to address this current limitation. Third, we lacked data on maternal infection, inflammation, stress, and physical activity levels and could not determine the extent to which these prognostic risk factors may have influenced nutrient availability or poor birth outcomes [ 44 ].
In conclusion, we did not observe a statistically significant effect of fortified BEP supplements and IFA tablets on SGA prevalence, as compared to IFA tablets alone in rural Burkina Faso, although small positive effects were noticed on birth weight, GA, and LBW prevalence.
Exploratory analyses suggests that prenatal BEP supplementation was more beneficial for mothers that enter pregnancy more adequately nourished. MISAME-III substudies will evaluate the efficacy of prenatal BEP and IFA tablets on additional maternal and child biochemical parameters to provide more insight in mechanisms of action and the clinical relevance of providing BEP supplementation.
The estimated difference in birth weight between the women who received the BEP supplement and IFA intervention and those who received only iron and folic acid control is shown as a function of the percentiles of maternal BMI. BEP, balanced energy—protein; BMI, body mass index; IFA, iron—folic acid.
The estimated difference in birth length between the women who received the BEP supplement and IFA intervention and those who received only iron and folic acid control is shown as a function of the percentiles of maternal BMI.
The authors thank all the women from Boni, Dohoun, Karaba, Dougoumato II, Koumbia, and Kari who participated in the study; the data collection team; and Henri Somé from AFRICSanté. We thank Nutriset France for donating the BEP supplements.
Article Authors Metrics Comments Media Coverage Peer Review Reader Comments Figures. Abstract Background Providing balanced energy—protein BEP supplements is a promising intervention to improve birth outcomes in low- and middle-income countries LMICs ; however, evidence is limited.
Conclusions The MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. Trial registration ClinicalTrials. gov NCT Author summary Why was this study done?
Previous studies showed that balanced energy—protein BEP supplementation led to a reduction in small-for-gestational age SGA and low birth weight LBW babies and stillbirth, and increased birth weight.
Conclusions on the impact of BEP should be interpreted with caution due to the large heterogeneity in supplement types administered and their timing, study populations, and quality of the study designs. There is a critical need for high-quality randomized controlled trials RCTs with adequate sample sizes, to assess the efficacy of BEP during pregnancy to support fetal growth and improve birth outcomes.
What did the researchers do and find? The trial did not provide evidence that BEP is efficacious in reducing SGA prevalence, but gestational duration was slightly longer, prevalence of LBW babies lower, and birth weight, birth length, and thoracic and arm circumference higher. What do these findings mean?
Our findings are consistent with previous research showing that prenatal BEP led to a reduction in LBW babies and increased birth weight. However, we did not observe a statically significant effect on SGA, in comparison to earlier evidence.
Future research in MISAME-III will assess additional maternal and child biochemical parameters to provide further insights into the clinical relevance of BEP supplementation.
Bhutta, The Hospital for Sick Children, CANADA Received: February 24, ; Accepted: April 27, ; Published: May 13, Copyright: © de Kok et al. Methods Our research was reported using the Consolidated Standards of Reporting Trials CONSORT checklist S1 CONSORT checklist [ 17 ].
Study design and participants The MISAME-III protocol was published previously [ 18 ]. Randomization and masking We randomly allocated women to the prenatal control or intervention group. Procedures Women in the intervention group received a daily BEP supplement and IFA tablet for the duration of their pregnancy.
Download: PPT. Table 1. Nutritional values of the BEP supplement for pregnant women a. Statistical analysis All analyses were documented in the MISAME-III statistical analysis plan prior to analysis, which was validated on October 24, and published online on November 3, [ 28 ].
Results From October 30, to December 12, , 2, women were assessed for eligibility, of whom 1, were randomized control and intervention. Table 3. Fetal loss and stillbirth prevalence, by prenatal study group.
Table 4. Efficacy of prenatal BEP supplementation on birth outcomes. Fig 2. Treatment efficacy on birth weight across the distribution of birth weight. Fig 3. Treatment efficacy on birth length across the distribution of birth length.
Discussion The MISAME-III trial did not provide evidence that prenatal fortified BEP supplementation was efficacious in reducing SGA prevalence. Supporting information. S1 CONSORT checklist.
Checklist of information to include when reporting a cluster randomized trial. CONSORT, Consolidated Standards of Reporting Trials. s DOCX. S1 Table. Complete cases analysis of primary and secondary outcomes. S2 Table. Per-protocol analyses of primary and secondary outcomes.
S3 Table. Subgroup analysis by potential treatment effect modifiers of SGA. SGA, small-for-gestational age. S1 Fig. Treatment efficacy on birth weight across the distribution of maternal BMI. s TIF. S2 Fig.
Treatment efficacy on birth length across the distribution of maternal BMI. Acknowledgments The authors thank all the women from Boni, Dohoun, Karaba, Dougoumato II, Koumbia, and Kari who participated in the study; the data collection team; and Henri Somé from AFRICSanté.
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