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Pragmatic cluster randomised trial of a free telephone-based health coaching program to support women in managing weight gain during pregnancy: the Get Healthy in Pregnancy Trial.
Clements, V, Leung, K, Khanal, S, Raymond, J, Maxwell, M, Rissel, C
BMC health services research. 2016;(1):454
Abstract
BACKGROUND Excessive gestational weight gain can result in poor maternal and child health outcomes. Estimates from single studies indicate the prevalence of excessive gestational weight gain in Australia could lie between 38 and 67 %. The risk of excessive weight gain can be reduced through healthy eating and exercise. We describe the rationale and methods of the Get Healthy in Pregnancy Service, a trial service which aims to support women in achieving appropriate gestational weight gain through an existing telephone-based health coaching service. METHODS/DESIGN This study aims to compare the effectiveness of a telephone-based health coaching program versus provision of information only in supporting pregnant women to achieve appropriate gestational weight gain. A pragmatic stratified clustered randomised controlled trial will be conducted with 710 women who present to 5 hospitals for their first antenatal appointment during the recruitment period (6-8 months), have a pre-pregnancy body mass index (BMI) ≥ 18.50 (healthy weight or above), are 18 years and over, singleton gestation, English speaking, have no pre-existing medical conditions that may limit their ability to exercise or require a restricted diet and are 18 weeks or less gestation. Hospitals will be randomised into one of two intervention models: a) information only; or b) information plus 10 telephone-based health coaching sessions with a university qualified coach. Both interventions will set a weight-range target with pregnant women. The women attending antenatal clinics at participating hospitals will be screened at their initial hospital appointment to assess their eligibility. Women recruited to the trial will have a number of measures recorded including anthropometrics (self-reported height and weight) and dietary and physical activity scores during and following pregnancy. These measurements will be collected at baseline (prior to 18 weeks gestation), 36 weeks gestation and 12 months post-birth. DISCUSSION This study responds to a need for an effective intervention that targets excessive gestational weight gain at a population level. This study investigates the potential for an innovative intervention combining two existing services; a free state-wide telephone-based health coaching service and hospital-based antenatal care to support pregnant women to achieve healthy weight gain during pregnancy. The use of existing services provides the potential for immediate post-study implementation. While the impacts of telephone-based lifestyle programmes have been tested in a number of settings, there are few studies which evaluate the effectiveness and acceptability of telephone support in achieving healthy gestational weight gain in association with routine antenatal care. TRIAL REGISTRATION ACTRN12615000397516 (Registration date: 26 June 2014, retrospectively registered).
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Neither folic acid supplementation nor pregnancy affects the distribution of folate forms in the red blood cells of women.
Hartman, BA, Fazili, Z, Pfeiffer, CM, O'Connor, DL
The Journal of nutrition. 2014;(9):1364-9
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It is not known whether folate metabolism is altered during pregnancy to support increased DNA and RNA biosynthesis. By using a state-of-the-art LC tandem mass spectrometry technique, the aim of this study was to investigate differences in RBC folate forms between pregnant and nonpregnant women and between nonpregnant women consuming different concentrations of supplemental folic acid. Forms of folate in RBCs were used to explore potential shifts in folate metabolism during early erythropoiesis. Total RBC folate and folate forms [tetrahydrofolate; 5-methyltetrahydrofolate (5-methyl-THF); 4α-hydroxy-5-methyl-tetrahydrofolate (an oxidation product of 5-methyl-THF); 5-formyl-tetrahydrofolate; and 5,10-methenyl-tetrahydrofolate] were measured in 4 groups of women (n = 26): pregnant women (PW) (30-36 wk of gestation) consuming 1 mg/d of folic acid, and nonpregnant women consuming 0 mg/d (NPW-0), 1 mg/d (NPW-1), and 5 mg/d (NPW-5) folic acid. The mean ± SD RBC folate concentration of the NPW-0 group (890 ± 530 nmol/L) was lower than the NPW-1 (1660 ± 350 nmol/L) and NPW-5 (1980 ± 570 nmol/L) groups as assessed by microbiologic assay (n = 26, P < 0.0022). No difference was found between the NPW-1 and NPW-5 groups. We detected 5-methyl-THF [limit of detection (LOD) = 0.06 nmol/L] in all groups and tetrahydrofolate (LOD = 0.2 nmol/L) in most women regardless of methylenetetrahydrofolate reductase genotype. Most women consuming folic acid supplements had detectable concentrations of 5,10-methenyl-tetrahydrofolate (LOD = 0.31 nmol/L). However, there was no difference in the relative distribution of 5-methyl-THF (83-84%), sum of non-methyl folates (0.6-3%), or individual non-methyl folate forms in RBCs across groups. We conclude that although folic acid supplementation in nonpregnant women increases RBC total folate and the concentration of individual folate forms, it does not alter the relative distribution of folate forms. Similarly, distribution of RBC folate forms did not differ between pregnant and nonpregnant women. This trial was registered at clinicaltrials.gov as NCT01741077.
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Comparison of oxidative stress in pregnancies with and without first trimester iron supplement: a randomized double-blind controlled trial.
Korkmaz, V, Ozkaya, E, Seven, BY, Duzguner, S, Karsli, MF, Kucukozkan, T
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2014;(15):1535-8
Abstract
OBJECTIVE Iron supplementation was found to be a cause of oxidative stress. The aim of this study was to compare oxidative stress in pregnancies with and without iron supplementation in the first trimester pregnancies. METHODS One hundred and eight women in the first trimester of normal pregnancies were randomly assigned to three groups. Patients were grouped as following: Group 1 received placebo (n = 36), group 2 received folate supplementation (n = 36) and group 3 was directed to the iron supplementation (n = 36). Oxidative stress was assessed at 14th week of gestation by the utilization of serum γ-glutamyl transferase level. Pregnancies were followed until delivery. Relationship between the oxidative stress and pregnancy outcome was assessed among groups. RESULTS Mean age was similar among groups, mean gravidity and parity were significantly lower in group with Fe supplementation (p < 0.05). Maternal weight and weight gain during pregnancy were also significantly lower in group 3 (p < 0.05). Mean serum albumin levels were similar among groups while serum γ-glutamyl transferase (GGT) levels were significantly higher in group 3. There were 10 cases of oligohydramnios in group 3, two cases in group 2 and no cases in group 1 (p < 0.001). CONCLUSION Iron supplementation during first trimester pregnancy was found to be associated with an increased oxidative stress.
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Comparing the pharmacokinetics of doxylamine/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy.
Matok, I, Clark, S, Caritis, S, Miodovnik, M, Umans, J, Hankins, G, Koren, G
Journal of clinical pharmacology. 2013;(3):334-8
Abstract
Although Diclectin (doxylamine/pyridoxine delayed-released combination) is widely used in Canada, its pharmacokinetics (PK) during pregnancy has never been described. The objective of this study was to compare the PK of doxylamine/pyridoxine delayed-released combination in pregnant versus nonpregnant women. The apparent clearances (CL) of doxylamine and pyridoxal 5'-phosphate (PLP; the active metabolite of vitamin B(6) ) during the first-trimester pregnancy in women who participated in a Diclectin randomized trial were compared with those of healthy, adult, nonpregnant women who participated in a voluntary PK trial. Eighteen nonpregnant women were compared with 50 pregnant women who were treated with Diclectin. There was no difference in the apparent CL of doxylamine in women in their first trimester of pregnancy when compared with nonpregnant women on day 4 (median = 196.7 vs 249.5 mL/h/kg, respectively, P = .065), day 8 (median = 248.4 vs 249.5 mL/h/kg, respectively, P = .82), and day 15 (median = 200.9 vs 249.5 mL/h/kg, respectively, P = .55). No difference was found in the apparent CL of PLP on day 15 (median = 342.3 vs 314.7 mL/h/kg, respectively, P = .92). There was no pregnancy-induced effect in the apparent CL of either doxylamine or PLP in women during the first trimester of pregnancy despite the existence of morning sickness.
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Antenatal iron supplements consumed daily produce oxidative stress in contrast to weekly supplementation in Mexican non-anemic women.
Viteri, FE, Casanueva, E, Tolentino, MC, Díaz-Francés, J, Erazo, AB
Reproductive toxicology (Elmsford, N.Y.). 2012;(1):125-32
Abstract
UNLABELLED Universal prenatal daily supplementation with iron (60-120mg iron) plus folic acid (0.4mg), as recommended by INACG/WHO/UNICEF, prevents anemia where iron deficiency is prevalent but may be excessive for non-anemic women. Weekly supplementation with 120mg iron plus various amounts of folic acid similarly prevents significant anemia. OBJECTIVE Determine, in non-anemic pregnant women, if oxidative stress is produced by recommended daily or weekly supplementation schemes. PROCEDURE 100 non-anemic pregnant women, 30% iron-deficient at week 20, were randomly supplemented daily followed by weekly, each for 8 weeks, or in reversed order. RESULTS With daily supplementation thio-barbituric-acid-reacting-substances (TBARS) increased significantly and high serum ferritin, iron, and excessively elevated hemoglobin occurred near term. During weekly supplementation significant anemia and high iron parameters were prevented, and elevated TBARS declined. CONCLUSION In non-anemic pregnant women both schemes prevented significant anemia. Oxidative stress occurred only during daily supplementation periods. Weekly supplementation appears safer.
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Comparison of leucine and dispensable amino acid kinetics between Indian women with low or normal body mass indexes during pregnancy.
Kurpad, AV, Dwarkanath, P, Thomas, T, Mhaskar, A, Thomas, A, Mhaskar, R, Jahoor, F
The American journal of clinical nutrition. 2010;(2):320-9
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BACKGROUND Evidence suggests that in women with a normal to high body mass index (BMI; in kg/m(2)), the extra amino acids needed during pregnancy are met through reduced oxidation. It is not known whether a woman with a low BMI can make this adaptation successfully. OBJECTIVE The objective was to measure and compare leucine kinetic parameters and alanine-nitrogen, glutamine amide-nitrogen, and glycine and cysteine fluxes in Indian women with a low and normal BMI in early and midpregnancy. DESIGN Fasted- and fed-state kinetics were measured by infusing 1-[(13)C]leucine, [(2)H(2)]cysteine, [(2)H(2)]glycine, [5-(15)N]glutamine, and [(15)N]alanine in groups of 10 women with a low BMI (<18.5) and 10 women with a normal BMI (18.5-25) in the first and second trimesters of pregnancy. RESULTS Leucine, glutamine, glycine, and cysteine fluxes were faster in women with a low BMI in both trimesters, but there was no difference in alanine flux between groups. This difference was explained in the first trimester by a higher proportion of fat-free mass in low-BMI women. Leucine oxidation and percentage of dietary leucine oxidized were higher in low-BMI women in both trimesters, but nonoxidative disposal was not different between groups. CONCLUSIONS Although they use dietary protein less efficiently, low-BMI women maintain net protein synthesis at the same rate as do normal-BMI women and produce similar quantities of labile nitrogen for the de novo synthesis of other dispensable amino acids such as glycine and cysteine. The extra amino acids required for increased maternal protein synthesis during pregnancy are provided by an overall decrease in amino acid catabolism in women with normal or low BMI.
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Angiogenesis and vasculogenesis in pregnancy.
Zygmunt, M, Herr, F, Münstedt, K, Lang, U, Liang, OD
European journal of obstetrics, gynecology, and reproductive biology. 2003;:S10-8
Abstract
An adequate nutrient and substrate supply is essential for normal intrauterine development of the fetus. Disturbances in uterine blood supply are associated with higher perinatal morbidity and mortality caused by preterm delivery, pre-eclampsia or intrauterine growth restriction. Adaptation of the uterine vasculature to the rising needs of the fetus occurs through both vasodilation and development of new vessels. Angiogenesis is the process of neovascularization from pre-existing blood vessels in response to hypoxia or substrate demands of tissues. The endometrium, decidua and placenta are sources rich of angiogenic growth factors. In general, the angiogenic process is initiated by growth factors such as bFGF, VEGF, or placental growth factor (PlGF). Through a complex signal transduction machinery mediated by respective receptor-tyrosine kinases, an increase in the permeability of the maternal vessels is achieved to permit growth and invasion of endothelial cells. Their chemotactic migration, formation of a vessel lumen, and functional maturation of new capillaries complete the angiogenic process that involves the expression of specific adhesion receptors and extracellular matrix-degrading proteases. During vasculogenesis, endothelial progenitor cells--angioblasts--form a primitive vascular network. This process occurs mainly during fetal development, although recruitment of angioblasts from bone marrow and peripheral blood in response to ischemic insult have been described in adults. Our recent data indicate a novel function for human chorionic gonadotropin (hCG), a hormonal factor of trophoblastic origin in uterine adaptation to early pregnancy as well as in tumor invasion and underline the importance of hCG as an yet unrecognized angiogenic factor. Although there are striking similarities between, on the one hand, tumor invasion and tumor-induced vascularization and, on the other hand, trophoblast invasion and placental development, our understanding of the different molecular and functional aspects of these two different processes, in particular, the self-limitation of the trophoblastic invasion and vessels formation during gestation might allow the establishment of new therapeutic strategies for the treatment of both tumor and pregnancy related pathology.
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Measuring energy expenditure in habitually active and sedentary pregnant women.
Stein, AD, Rivera, JM, Pivarnik, JM
Medicine and science in sports and exercise. 2003;(8):1441-6
Abstract
PURPOSE To describe patterns of energy expenditure (EE) during pregnancy and to assess the convergent validity of three methods of estimating EE. METHODS We administered heart rate (HR) telemetry, accelerometry, and a physical activity record (PAR) over two consecutive days at weeks 20 and 32 of pregnancy and 12 wk postpartum to 28 habitually active and 28 habitually sedentary women. RESULTS Mean daily waking-time EE at 20 wk by HR telemetry was 1814 (SD 443) kcal in active women and 1738 (448) kcal in sedentary women (P > 0.50), and did not change over the period of study (for active women P > 0.40; for sedentary women P > 0.70). Compared with HR telemetry, accelerometry underestimated EE by approximately 400 kcal x d-1, and the PAR overestimated EE by a similar amount, at all time periods in both active and sedentary women. EE, expressed per unit body weight, was consistently higher for active than for sedentary women during pregnancy. Pairwise correlations between methods ranged from 0.37 to 0.90 across time periods in both active and sedentary women. Correlations were lower (range 0.07-0.81) when adjusted for the length of the recording day. CONCLUSIONS All methods were sensitive to variation in both the rate of EE and the duration over which activity was monitored. Accelerometry and PAR are useful methods for categorizing EE in epidemiologic studies among pregnant women but absolute estimates are biased relative to HR.
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A micronutrient-fortified beverage prevents iron deficiency, reduces anemia and improves the hemoglobin concentration of pregnant Tanzanian women.
Makola, D, Ash, DM, Tatala, SR, Latham, MC, Ndossi, G, Mehansho, H
The Journal of nutrition. 2003;(5):1339-46
Abstract
Maternal malnutrition continues to be a major contributor to adverse reproductive outcomes in developing countries, despite longstanding efforts to fortify foods or to distribute medicinal supplements to pregnant women. The objective of this study was to test the effect of a micronutrient-fortified beverage containing 11 micronutrients (iron, iodine, zinc, vitamin A, vitamin C, niacin, riboflavin, folate, vitamin B-12, vitamin B-6 and vitamin E) on the hemoglobin, iron and vitamin A status of pregnant women in Tanzania. A group of 259 pregnant women with gestational ages of 8 to 34 wk were enrolled in a randomized double-blind controlled trial in which study women received 8 wk of supplementation. Hemoglobin, ferritin and dried blood spot retinol were measured at baseline and at the end of the supplementation period. The supplement resulted in a 4.16 g/L increase in hemoglobin concentration and a 3 micro g/L increase in ferritin and reduced the risk of anemia and iron deficiency anemia by 51 and 56%, respectively. The risk of iron deficiency was reduced by 70% among those who had iron deficiency at baseline and by 92% among those who had adequate stores. The micronutrient-fortified beverage may be a useful and convenient preventative measure, one that could help improve the nutritional status of women both before and during pregnancy and thereby help avoid some of the potential maternal and fetal consequences of micronutrient deficiencies.
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Maternal serum triglyceride at 24--32 weeks' gestation and newborn weight in nondiabetic women with positive diabetic screens.
Kitajima, M, Oka, S, Yasuhi, I, Fukuda, M, Rii, Y, Ishimaru, T
Obstetrics and gynecology. 2001;(5 Pt 1):776-80
Abstract
OBJECTIVE To determine whether elevated midpregnancy maternal serum lipid levels predict newborn weight at term and the risk of large for gestational age (LGA) infants in women with positive diabetic screen but normal glucose tolerance test. METHODS Japanese gravidas who had positive diabetic screens and normal 75-g oral glucose tolerance tests (GTT) at 24--32 weeks were enrolled. Subjects with complications, including diabetes, hypertension, or fetal anomalies were excluded, as were women with multifetal gestations. Fasting serum triglyceride, free fatty acids, and total cholesterol levels were measured at the time of GTT. We tested the association between maternal variables and birth weight by univariable analysis. We used multivariable analysis to test whether the association between fasting lipids and birth weight was independent of prepregnant maternal body mass index (BMI), maternal weight gain during pregnancy, and plasma glucose levels at GTT. We also used multiple logistic regression analysis to determine whether maternal hyperlipidemia, defined as more than the 75th percentile of each lipid, is a risk factor for having an LGA infant. RESULTS We enrolled 146 subjects. Among measured maternal lipids, only triglyceride levels correlated with birth weight in univariable analysis (r = 0.22, P =.009). Birth weight also was correlated with prepregnant maternal BMI (r = 0.18, P =.04) and fasting plasma glucose levels (r = 0.17, P =.04). The association between maternal fasting triglyceride level and birth weight remained significant after adjusting for prepregnant BMI, maternal weight gain, fasting plasma glucose levels, fetal gender, and gestational age at birth (P =.01). Logistic regression analysis showed that fasting maternal hypertriglyceridemia (over 259 mg/dL) was the significant predictor of LGA infants, independent of prepregnant BMI, maternal weight gain, and maternal plasma glucose levels (odds ratio 11.6; 95% confidence interval 1.1, 122; P =.04). CONCLUSION In women with positive diabetic screens but normal GTTs, fasting triglyceride levels at 24-32 weeks correlated positively with newborn weight at term, independent of maternal plasma glucose levels and obesity. Maternal fasting serum triglyceride levels in midpregnancy might be an independent predictor of fetal macrosomia in those women.