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Evidence of lifestyle interventions in a pregnant population with chronic hypertension and/or pre-existing diabetes: A systematic review and narrative synthesis.
Goddard, L, Patel, R, Astbury, NM, Tucker, K, McManus, RJ
Pregnancy hypertension. 2023;31:60-72
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Chronic hypertension complicates ≤5 % of pregnancies, and those entering pregnancy with a pre-existing diagnosis of diabetes has a global prevalence of between 0.5 % and 2.6 %. The aim of this study was to collate the evidence around lifestyle interventions during pregnancy for women with chronic hypertension and/or pre-existing diabetes (type 1 and type 2). This study is a systematic review and meta-analysis of nine randomised controlled trials. Results show lack of clarity and data on the effect of lifestyle interventions in pregnant women with chronic hypertension and/or pre-existing diabetes, thereby exposing key gaps in the literature. Authors conclude that there is a shortage of primary interventional studies examining the effect of lifestyle interventions in high-risk pregnant populations who enter pregnancy with chronic conditions.
Abstract
BACKGROUND Pregnant people with chronic hypertension, pre-existing diabetes or both are at high risk of developing cardiovascular disease. Lifestyle interventions play an important role in disease management in non-pregnant populations. AIM: To review the existing evidence of randomised controlled trials (RCTs) that examine lifestyle interventions in pregnant people with chronic hypertension and/or pre-existing diabetes. METHODS A systematic review and narrative synthesis was conducted. Five electronic databases were searched from inception to April 2021 for RCTs evaluating antenatal lifestyle interventions in people with chronic hypertension and/or pre-existing diabetes with outcomes to include weight or blood pressure change. RESULTS Nine randomised controlled trials including 7438 pregnant women were eligible. Eight studies were mixed pregnant populations that included women with chronic hypertension and/or pre-existing diabetes. One study included only pregnant women with pre-existing diabetes. Intervention characteristics and procedures varied and targeted diet, physical activity and/or gestational weight. All studies reported weight and one study reported blood pressure change. Outcome data were frequently unavailable for the subset of women of interest, including subgroup data on important pregnancy and birth complications. Eligibility criteria were often ambiguous and baseline data on chronic hypertension was often omitted. CONCLUSION A lack of primary interventional trials examining the effect of lifestyle interventions on weight and blood pressure outcomes in pregnant populations with chronic hypertension and/or pre-existing diabetes was evident. Lifestyle modification has the potential to alter disease progression. Future trials should address the ambiguity and frequent exclusion of these important populations.
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Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women.
Alomairah, SA, Knudsen, SP, Roland, CB, Molsted, S, Clausen, TD, Bendix, JM, Løkkegaard, E, Jensen, AK, Larsen, JE, Jennum, P, et al
International journal of environmental research and public health. 2023;20(7)
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Pregnant women benefit from physical activity (PA) during pregnancy. The aim of this study was to assess the effect of the FitMum PA interventions on sleep quantity and quality and sedentary time (SED). This study was a secondary analysis of the FitMum study which included 220 healthy pregnant women. Participants were randomised to one of three groups. Results showed that pregnant women are prone to low sleep quality and high SED, which worsens as pregnancy progresses. Pregnant women who received structured supervised exercise training had better sleep quality and less SED than pregnant women receiving standard prenatal care when self-reported. Furthermore, when measured by a consumer activity tracker, no differences were observed between groups. Authors conclude that interventions that increase PA levels might improve sleep quality and decrease SED in pregnant women. Future behavioural interventions targeting pregnant women should include evidence-based content to improve sleep quality and reduce SED.
Abstract
Pregnancy is often associated with poor sleep and high sedentary time (SED). We investigated the effect of physical activity (PA) interventions on sleep and SED in pregnant women. A secondary analysis of a randomized controlled trial (n = 219) explored the effect of structured supervised exercise training (EXE) or motivational counseling on PA (MOT) compared to standard prenatal care (CON) on sleep and SED during pregnancy. Three times during pregnancy, sleep was determined by the Pittsburgh Sleep Quality Index (PSQI) and SED by the Pregnancy Physical Activity Questionnaire (PPAQ). Also, a wrist-worn consumer activity tracker measured sleep and SED continuously. Data from the activity tracker confirmed that sleep time decreases, and SED increases by approx. 30 and 24 min/day, respectively, from baseline (maximum gestational age (GA) week 15) to delivery. Compared to CON, the global PSQI score was better for EXE in GA week 28 (-0.8 [-1.5; -0.1], p = 0.031) and for both EXE and MOT in GA week 34 (-1 [-2; -0.5], p = 0.002; -1 [-2; -0.1], p = 0.026). In GA week 28, SED (h/day) from PPAQ was lower in EXE compared to both CON and MOT (-0.69 [-1; -0.0], p = 0.049; -0.6 [-1.0; -0.02], p = 0.042). In conclusion, PA interventions during pregnancy improved sleep quality and reduced SED.
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Effectiveness of a minimally processed food-based nutritional counselling intervention on weight gain in overweight pregnant women: a randomized controlled trial.
Sartorelli, DS, Crivellenti, LC, Baroni, NF, de Andrade Miranda, DEG, da Silva Santos, I, Carvalho, MR, de Lima, MC, Carreira, NP, Chaves, AVL, Manochio-Pina, MG, et al
European journal of nutrition. 2023;62(1):443-454
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Excessive gestational weight gain exposes the woman and the child to a higher risk of harmful health outcomes in the short and long term. Dietary patterns based on the substitution of meals made with unprocessed or minimally processed foods for the consumption of ultra-processed items can be partly blamed for the exponential global growth in the incidence of obesity. The main aim of this study was to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods rather than ultra-processed products. This study is a two-armed parallel randomised controlled trial conducted among overweight, pregnant women receiving prenatal care in seven primary health units. Participants (n=350) were randomly allocated into the intervention group (IG) or control group (CG). The women allocated into the IG, in addition to the usual prenatal care, were invited to participate in three individualised nutritional counselling sessions conducted by trained nutritionists. Results show that even though there were more women in the IG who had increased their daily intake of minimally processed foods and vegetables at lunch time when compared to the CG, this was not statistically significant. Additionally, there weren’t any differences between the groups in relation to physical activity. Authors conclude that their study was unprecedented in demonstrating that a nutritional counselling intervention based on the NOVA food classification system, together with the practice of physical activity, is effective in preventing excessive gestational weight gain in overweight pregnant women.
Abstract
PURPOSE This study aimed at evaluating the effectiveness of a nutritional counselling intervention based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed products, and the practice of physical activities to prevent excessive gestational weight gain in overweight pregnant women. METHODS This was a two-armed, parallel, randomized controlled trial conducted in primary health units of a Brazilian municipality from 2018 to 2021. Overweight, adult pregnant women (n = 350) were randomly assigned to control (CG) or intervention groups (IG). The intervention consisted of three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods rather than ultra-processed products, following the NOVA food classification system, and the practice of physical activities. The primary outcome was the proportion of women whose weekly gestational weight gain (GWG) exceeded the Institute of Medicine guidelines. Adjusted logistic regression models were employed. RESULTS Complete data on weight gain were available for 121 women of the IG and 139 of the CG. In modified intention-to-treat analysis, there was a lower chance of the IG women having excessive GWG [OR 0.56 (95% CI 0.32, 0.98), p = .04], when compared to the CG. No between-group differences were observed for the other maternal outcomes investigated. CONCLUSION The present study was unprecedented in demonstrating that nutritional counselling based on the NOVA food classification system, together with encouraging the practice of physical activity, is effective in preventing excessive weight gain in overweight pregnant women. TRIAL REGISTRATION Registered on July 30th 2018 at Brazilian Registry of Clinical Trials (RBR-2w9bhc).
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The effect of selenium supplementation in pregnant women on maternal, fetal, and newborn outcomes: a systematic review and meta-analysis.
McDougall, AR, Dore, G, Aboud, L, Makama, M, Nguyen, PY, Mills, K, Sanderson, B, Hastie, R, Ammerdorffer, A, Vogel, JP
American journal of obstetrics & gynecology MFM. 2023;5(11):101160
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Observational data show preterm birth risk is increased with low maternal selenium serum levels. Selenium is routinely included in supplements marketed to pregnant women, although studies have drawn conflicting findings about whether it provides benefit. The aim of this study was to identify and analyse the available interventional and observational evidence of the effect of selenium supplementation during pregnancy on preterm birth (PTB) prevention. This study was a systematic review of thirty-two studies - 5 observational studies and 27 randomised trials. Results showed that there was no association between selenium supplementation and any clinical outcome. Authors concluded that since there was insufficient evidence in all outcomes, selenium supplementation during pregnancy cannot be recommended as a part of routine antenatal care.
Abstract
OBJECTIVE Low maternal selenium status has been associated with poor pregnancy outcomes, including preterm birth. This study aimed to evaluate available evidence of the effects of selenium supplementation during pregnancy on preterm birth and related maternal, fetal, and newborn outcomes. DATA SOURCES MEDLINE, Embase, CINAHL, Global Index Medicus, and the Cochrane Library were systematically searched on June 23, 2022, without language or time restrictions. STUDY ELIGIBILITY CRITERIA Randomized controlled trials and nonrandomized interventional studies were included if they compared the effects of selenium supplementation with placebo or no treatment among pregnant women. The review protocol was registered in the International Prospective Register of Systematic Reviews (identification number: CRD42022383669). METHODS For outcomes reported by ≥1 study, a meta-analysis was conducted. Because of the small number of studies and high clinical heterogeneity between populations, random-effects models were used. The Risk of Bias 2 and Risk Of Bias In Non-randomized Studies - of Interventions tools were used to assess study quality, and Grading of Recommendations Assessment, Development, and Evaluation analysis was used to determine the certainty of evidence for each outcome. RESULTS Literature searches identified 5105 unique records, and 32 studies met the eligibility criteria. Of note, 11 reports were not included for analysis following research integrity assessments. Moreover, 10 trials and 3 observational studies met the inclusion criteria; however, only 8 trials (1851 women) and 1 prospective cohort study (71,728 women) reported on at least 1 review outcome. Our results could not determine the effect of selenium supplementation on preterm birth at <37 weeks of gestation (relative risk, 0.65; 95% confidence interval, 0.26-1.63; very low certainty evidence) and <34 weeks of gestation (relative risk, 1.05; 95% confidence interval, 0.59-1.44; very low certainty evidence). CONCLUSION There is limited evidence on the effects of selenium supplementation during pregnancy. Further trials, with larger sample sizes, more representative populations, and reliable assessment of maternal selenium status at trial entry, are required.
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Advancements in Nutritional Strategies for Gestational Diabetes Management: A Systematic Review of Recent Evidence.
Sánchez-García, JC, Saraceno López-Palop, I, Piqueras-Sola, B, Cortés-Martín, J, Mellado-García, E, Muñóz Sánchez, I, Rodríguez-Blanque, R
Journal of clinical medicine. 2023;13(1)
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Gestational Diabetes Mellitus (GDM) causes hyperglycaemia due to the deficit of insulin during pregnancy. Dietary and lifestyle management plays a vital role in maintaining glycaemic control in women with GDM to avoid health risks to the mother and baby. Therefore, this systematic review of fourteen randomised controlled trials evaluated the latest research advancements to identify effective nutritional strategies for managing hyperglycaemia in women with GDM. Among all the dietary strategies implemented in the included randomised controlled trials, probiotic supplementation and supplementation of probiotics and vitamin D were most effective in GDM. Further robust studies are required to evaluate the potential effectiveness of different nutritional strategies for managing GDM. Healthcare professionals can use the results of this systematic review to understand the latest evidence supporting nutritional strategy for women with GDM and the need for personalised support for managing hyperglycaemia in GDM.
Abstract
Gestational diabetes mellitus (GDM) is defined as hyperglycaemia first detected at any time during pregnancy with values lower than those determined by the WHO for diabetes diagnosis in adults. This pathology, with a worldwide prevalence of 13.4%, causes significant maternal and foetal risks. The first line of treatment consists of maintaining normo-glycaemia through an adequate diet and lifestyle changes. The aim is to synthesize the scientific evidence updating the nutritional recommendations for the effective management of GDM. A systematic review of the scientific literature was conducted following the PRISMA guidelines. Randomized clinical trials published within the last five years and providing information on nutritional recommendations to achieve an effective management of gestational diabetes were selected. The databases searched were PubMed, the WOS Core Collection, SCOPUS, and CINAHL, using the MeSH terms: "Diabetes, Gestational"; "Nutrition Assessment (nutrition*)"; "Diet"; "Eating"; and "Food"; with the Boolean operators "AND" and "OR". The PEDro scale (Physiotherapy Evidence Database) was used to assess the scientific quality of the studies, with a mean score of 8.9, indicating an average good scientific quality. Results: A total of 809 papers were collected, of which, after applying the inclusion and exclusion criteria, 14 randomized clinical trials were selected. Probiotic supplementation and co-supplementation with vitamin D have been found to be the most beneficial options for both mothers with GDM and neonates, but the most effective regimens are not known. Diets enriched with extra virgin olive oil (EVOO) and oat bran, as well as some recommendations focused on carbohydrates also seem effective, as well as diets designed for this group of women with GDM such as "CHOICE". Conclusions: Although there are numerous proposals that have been published in recent years focused on the diet of women with GDM in order to improve their results and those of their children, it is the supplementation with probiotics and the co-supplementation with vitamin D that is most agreed upon as beneficial; however, more research is needed into which protocols are most effective. Other proposals that could also be beneficial should be further studied.
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The effect of probiotics on gestational diabetes and its complications in pregnant mother and newborn: A systematic review and meta-analysis during 2010-2020.
Mahdizade Ari, M, Teymouri, S, Fazlalian, T, Asadollahi, P, Afifirad, R, Sabaghan, M, Valizadeh, F, Ghanavati, R, Darbandi, A
Journal of clinical laboratory analysis. 2022;36(4):e24326
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Gestational diabetes (GD) refers to glucose intolerance in pregnant women at 24–28 weeks without a history of diabetes that results in hyperglycaemia. Some studies suggest that probiotics are able to overcome insulin resistance in pregnant women with GD. The aim of this study was to investigate the inhibitory effects of probiotics supplementation on GD among pregnant women based on Randomized Controlled Trial studies during in the last 10 years (2010–2020). This study is a systematic review and meta-analysis of 28 studies. The age range of the pregnant women following the probiotics treatment was 18–40 years. Results show that taking probiotic supplements during pregnancy by women with GD has beneficial effects on the metabolic status, colostrum adiponectin levels, microbiome composition, and the maternal and infant health. However, 4 of the analysed studies did not find any significant effect for the probiotic intervention on the incidence of GD. Authors conclude that more homogeneous studies are needed to generalize the findings of this study. Thus, specific probiotic supplementation may be introduced as one of the adjuvant therapies for GD patients.
Abstract
This study was aimed to evaluate the effect of probiotics consumption on gestational diabetes (GD) and its complications in pregnant mother and newborn. The study was registered on PROSPERO (CRD42021243409) and all the enrolled articles were collected from four databases (Medline, Scopus, Embase, and Google Scholar) as randomized controlled trials (RCTs) from 2010 to 2020. A total of 4865 study participants from 28 selected studies were included in this review. The present meta-analysis showed that the consumption of probiotics supplementation has the potential to decrease GD-predisposing metabolic parameters such as blood glucose level, lipid profile, inflammation, and oxidative markers which may reduce GD occurrence among pregnant women.
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Vitamin D3 Supplementation in Overweight/Obese Pregnant Women: No Effects on the Maternal or Fetal Lipid Profile and Body Fat Distribution-A Secondary Analysis of the Multicentric, Randomized, Controlled Vitamin D and Lifestyle for Gestational Diabetes Prevention Trial (DALI).
Harreiter, J, Mendoza, LC, Simmons, D, Desoye, G, Devlieger, R, Galjaard, S, Damm, P, Mathiesen, ER, Jensen, DM, Andersen, LLT, et al
Nutrients. 2022;14(18)
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Vitamin D is an important fat-soluble vitamin with steroid hormone function. It is predominately known for its essential role in calcium homeostasis and bone mineralisation. The aim of this study was to assess the effects of a vitamin D supplementation with 1600 IU Vitamin D3 per day starting in early pregnancy versus placebo on maternal and foetal lipid parameters, body fat distribution as well as pregnancy outcomes. This study is a secondary analysis of the vitamin D And LIfestyle for gestational diabetes prevention trial (DALI) Vitamin D study, including overweight/obese pregnant women with normal glucose tolerance at randomization before 20 weeks’ gestation. Results show a significant increase of maternal vitamin D levels throughout pregnancy and in cord blood in the supplementation group compared with the placebo group. However, there weren’t any significant differences between the treatment arms in maternal lipid parameters nor in foetal lipid parameters or birth outcomes. Authors conclude that daily vitamin D3 supplementation in overweight/obese pregnant women with high levels of vitamin D sufficiency does not improve maternal or foetal lipid parameters, body fat distribution or pregnancy outcomes and should not be used in pregnancy for these indications.
Abstract
Vitamin D deficiency is a common finding in overweight/obese pregnant women and is associated with increased risk for adverse pregnancy outcome. Both maternal vitamin D deficiency and maternal obesity contribute to metabolic derangements in pregnancy. We aimed to assess the effects of vitamin D3 supplementation in pregnancy versus placebo on maternal and fetal lipids. Main inclusion criteria were: women <20 weeks' gestation, BMI ≥ 29 kg/m2. Eligible women (n = 154) were randomized to receive vitamin D3 (1600 IU/day) or placebo. Assessments were performed <20, 24-28 and 35-37 weeks and at birth. Linear regression models were used to assess effects of vitamin D on maternal and cord blood lipids. In the vitamin D group significantly higher total 25-OHD and 25-OHD3 levels were found in maternal and cord blood compared with placebo. Adjusted regression models did not reveal any differences in triglycerides, LDL-C, HDL-C, free fatty acids, ketone bodies or leptin between groups. Neonatal sum of skinfolds was comparable between the two groups, but correlated positively with cord blood 25-OH-D3 (r = 0.34, p = 0.012). Vitamin D supplementation in pregnancy increases maternal and cord blood vitamin D significantly resulting in high rates of vitamin D sufficiency. Maternal and cord blood lipid parameters were unaffected by Vitamin D3 supplementation.
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Association of vaginal bacterial communities and reproductive outcomes with prophylactic antibiotic exposure in a subfertile population undergoing in vitro fertilization: a prospective exploratory study.
Eskew, AM, Stout, MJ, Bedrick, BS, Riley, JK, Herter, BN, Gula, H, Jungheim, ES, Wylie, KM
F&S science. 2021;2(1):71-79
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Approximately 1 in 8 couples receive infertility services in their lifetime. However, despite the increasing usage of in vitro fertilisation (IVF) technologies, the success rate, as measured using live birth rates, is just <50% in women <35 years of age. A low-diversity, Lactobacillus-dominated microbiome in the female reproductive tract has been thought to be a sign of optimal reproductive health, whereas an increased microbial diversity has been shown to be associated with poorer reproductive outcomes. The aims of this study were to (a) explore the effect of prophylactic azithromycin treatment on the vaginal bacterial microbiome longitudinally throughout an IVF cycle and (b) determine whether the characteristics of the vaginal bacterial communities are associated with clinical outcomes. This study is an a priori prospective exploratory cohort study conducted as a part of an ongoing randomized, controlled noninferiority trial. Subjects in the parent trial were randomly assigned to an azithromycin group or no-azithromycin group. The female subjects of the parent trial who were aged between 18–43 years and undergoing the first IVF cycle with a fresh embryo transfer were eligible for this study (n=27). Results show that in vaginal microbiome samples taken at the time of egg retrieval and embryo transfer, changes in the taxonomic composition, alpha diversity, and beta diversity are not associated with azithromycin [antibiotic] exposure at the time of gonadotropin initiation. Furthermore, bacterial community structures at baseline are not predictive of those at the time of embryo transfer. Authors conclude that their findings highlight the importance of timing in the assessment of vaginal microbiome to determine its associations with reproductive outcomes.
Abstract
OBJECTIVE To determine whether prophylactic azithromycin is associated with the vaginal bacterial microbiome and clinical outcomes in subfertile women undergoing in vitro fertilization (IVF). DESIGN Prospective exploratory cohort study. SETTING Single academic fertility center. PATIENTS Subfertile women aged 18-43 years undergoing their first IVF cycle and fresh embryo transfer. INTERVENTION Primary exposure to prophylactic azithromycin (1 g orally) once at baseline. MAIN OUTCOME MEASURES The primary outcome was the effect of azithromycin on the vaginal microbiome compared with a no-azithromycin group at 3 time points throughout the IVF cycle (baseline, retrieval, and embryo transfer). The secondary outcomes were associations of vaginal bacterial communities with clinical outcomes. RESULTS A planned a priori exploratory cohort of 27 subjects (12 in the azithromycin treatment group and 15 in the no-azithromycin group) contributed 79 vaginal swabs for the analysis as part of an ongoing randomized, controlled noninferiority trial. No specific taxa were associated with azithromycin or pregnancy at any time point. Azithromycin did not affect alpha diversity or community stability. Although there were trends of a lower bacterial load and higher percentage of Lactobacillus species in the azithromycin group at the time of transfer, these were not statistically significant. In women who did not become pregnant, the percentage of Lactobacillus species was lower (P = .048; Hodges-Lehmann estimate of difference, 0.41; 95% confidence interval, 0.08-0.65) and the change in community composition over time was higher. The percentage of Lactobacillus species at baseline was not predictive of the percentage of Lactobacillus species at the time of embryo transfer. CONCLUSIONS Prophylactic azithromycin at baseline is not associated with changes in vaginal bacterial communities. Bacterial community features at the time of embryo transfer are associated with pregnancy. Bacterial community structures at baseline are not predictive of those at the time of embryo transfer. CLINICAL TRIAL REGISTRATION NUMBER NCT03386227.