OBJECTIVES: We aimed to establish the impact of including/excluding pregnancies with adverse neonatal outcomes when constructing GWG charts.
METHODS: This is an individual participant data analysis from 31 studies from low- and middle-income countries. We created a dataset that included all participants and a dataset restricted to those with no adverse neonatal outcomes: preterm < 37 wk, small or large for gestational age, low birth weight < 2500 g, or macrosomia > 4000 g. Quantile regression models were used to create GWG curves from 9 to 40 wk, stratified by prepregnancy BMI, in each dataset.
RESULTS: The dataset without the exclusion criteria applied included 14,685 individuals with normal weight and 4831 with overweight. After removing adverse neonatal outcomes, 10,479 individuals with normal weight and 3466 individuals with overweight remained. GWG distributions at 13, 27, and 40 wk were virtually identical between the datasets with and without the exclusion criteria, except at 40 wk for normal weight and 27 wk for overweight. For the 10th and 90th percentiles, the differences between the estimated GWG were larger for overweight (∼1.5 kg) compared with normal weight (<1 kg). Removal of adverse neonatal outcomes had minimal impact on GWG trajectories of normal weight. For overweight, the percentiles estimated in the dataset without the criteria were slightly higher than those in the dataset with the criteria applied. Nevertheless, differences were <1 kg and virtually nonexistent at the end of pregnancy.
CONCLUSIONS: Removing pregnancies with adverse neonatal outcomes has little or no influence on the GWG trajectories of individuals with normal and overweight.
OBJECTIVES: We examined whether the inclusion of folic acid in weekly IFA supplements conferred any benefit on hemoglobin (Hb) concentration, anemia reduction, or iron status [ferritin and soluble transferrin receptor (sTfR)], over iron alone.
METHODS: In this secondary analysis of a randomized controlled trial in Malaysia, n = 311 nonpregnant women (18-45 y old) received 60 mg Fe with either 0, 0.4, or 2.8 mg folic acid once-weekly for 16 wk. Fasting blood was collected at baseline and 16 wk. A generalized linear model (normal distribution with identity link) was used to assess Hb concentration at 16 wk (primary outcome).
RESULTS: At baseline, 84% of women had low folate status (plasma folate 0.05). Baseline plasma folate concentration did not modify the effect of treatment on Hb concentration at 16 wk. Among all women, the risks of anemia [risk ratio (RR): 0.65; 95% CI: 0.45, 0.96; P = 0.03] and iron deficiency based on ferritin (RR: 0.30; 95% CI: 0.20, 0.44; P
METHODS AND ANALYSIS: We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure.
ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBERS: ACTRN12619000818134 and NMRR-19-119-45736.
METHODS: We conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n=331) were randomised to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks.
RESULTS: At 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.
CONCLUSION: Weekly IFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed.
TRAIL REGISTRATION NUMBER: This trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12619000818134).