Effect of maternal calcium intake during pregnancy on children's blood pressure: A systematic review of the literature

<p>Abstract</p> <p>Background</p> <p>Calcium supplementation during pregnancy has been shown to reduce the incidence of hypertension in the mother, but the effects on the offspring are uncertain. Assessing the impact on the offspring is very important given the now large body of evidence indicating that blood pressure levels in childhood and young adulthood can be influenced by factors operating during fetal life. We conducted a systematic review of the literature to summarize the evidence supporting an association between maternal dietary calcium intake during pregnancy and blood pressure in the offspring.</p> <p>Methods</p> <p>A systematic review was performed to identify randomized, quasi-randomized and cohort studies reporting the relationship between offspring blood pressure or incidence of hypertension and levels of maternal dietary calcium intake during pregnancy, either from supplements (i.e. pills) or food. MEDLINE, EMBASE and the Cochrane Library Registry were searched for relevant trials.</p> <p>Results</p> <p>Two randomized trial and three observational studies were identified and included in this review. In 4 of the 5 studies, loss to follow-up was a serious concern. There was heterogeneity between the studies, particularly those conducted on children below 12 month of age. Results were more consistent among the studies including older children (1 to 9 years) where a higher maternal calcium intake was associated with a reduction of -1.92 mm Hg (95% CI -3.14 to -0.71) in offspring systolic blood pressure. One large randomized trial found a clinically and statistically significant reduction in the incidence of hypertension in 7-year-old children (RR = 0.59, 95% CI 0.39 to 0.90).</p> <p>Conclusion</p> <p>There is evidence in the literature to support an association between maternal calcium intake during pregnancy and offspring blood pressure. However, more research is needed to confirm these finding given the small sample sizes and the methodological problems in many of the studies conducted so far. More studies on populations with calcium deficit are also needed. If confirmed, these findings could have important public health implications. Calcium supplementation during pregnancy is simple and inexpensive and may be a way to reduce the risk of hypertension and its sequels in the next generation.</p

Maternal calcium supplementation during pregnancy and dental caries of children at 12 years of age: Follow-up of a randomized controlled trial

Objectives. To evaluate if calcium supplementation during pregnancy could have any influence on primary dentition measured as the reduction of dental caries of the child. Design. Individual randomized controlled trial. Setting. One hospital in Rosario, Argentina. Population. Random sample of 195 12-year-old children from a follow-up study of 614 women who were randomized during pregnancy to calcium supplementation or placebo. Methods. An independent researcher blinded to the group where the mothers were assigned performed a dental examination of the children. Main outcome measures. Proportion of children with at least one decayed, missing or filled teeth (DMFT/dmft) and mean number of decayed, missing or filled surfaces (DMFS/dmfs) per children. Results. Ninety-eight children were assessed in the calcium supplementation group and 97 in the placebo group. 63.3% of the children whose mother took calcium supplementation had at least one DMFT/dmft compared to 86.6% in the placebo group (<0.001). The children whose mother received the intervention had a 27% reduction in the risk of developing at least one DMFT/dmft (RR: 0.73, CI 95%: [0.62; 0.87]). Conclusions. This study shows a modeling effect of calcium intake during pregnancy on dental caries of the offspring. At around 12 years of age children whose mothers received calcium supplementation when pregnant showed a significant reduction in dental caries.Fil: Bergel, Eduardo. Organizacion Mundial de la Salud; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Rasines, María G.. No especifíca;Fil: Luetich, Alejandra. No especifíca;Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentin

Effects of the copper intrauterine device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in South Africa: a pragmatic randomized controlled trial

Background: The copper intrauterine device (IUD) is under-utilised in South Africa, where injectable progestin contraception (IPC) dominates contraception usage. There is a lack of robust comparative data on these contraceptive options to inform policy, programs, clinical counseling, and women’s choices. Methods: Within the context of a South African program to increase women’s access to the IUD, we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial of the IUD versus IPC at two South African hospitals. The target sample size was 7,000 women and the randomisation ratio was 1:1. The random sequence was computer-generated and group allocation was concealed in sealed, opaque, consecutively-numbered envelopes. Counselled, consenting women attending termination of pregnancy services were randomly assigned to IUD or IPC immediately post-termination. Condoms were promoted for the prevention of sexually-transmitted infections. The primary outcome was pregnancy; secondary outcomes were discontinuation, side-effects, and HIV acquisition and disease progression. Pregnancy and discontinuation outcomes are reported here. Results: The trial closed early with 2,493 participants randomised (IUD = 1,247, IPC = 1,246), due to international concerns regarding a possible association between IPC and HIV acquisition. Median follow-up was 20 months; 982 and 1000 participants were followed up in the IUD and IPC groups, respectively. Baseline group characteristics were comparable. Pregnancy occurred significantly less frequently among women allocated to the IUD than IPC: 56/971 (5.8 %) versus 83/992 (8.4 %), respectively; risk ratio (RR) 0.69, 95 % confidence interval (CI) 0.50 to 0.96; P = 0.025. There were more protocol violations in the IUD group; however, discontinuation rates were similar between IUD and IPC groups (141/855 [16.5 %] and 143/974 [14.7 %], respectively). Women in the IUD group were more likely to discontinue contraceptive use due to abdominal pain or backache and non-specific symptoms, and those in the IPC group due to oligo- or amenorhoea and lack of sexual activity. Conclusions: The IUD was significantly more effective in preventing pregnancy than IPC. Efforts to expand contraception options and improve access to the IUD in settings where it is under-utilised are worthwhile. This trial shows that randomising long-acting, reversible contraceptives is feasible. Trial registration: Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014)

Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

Background: Evidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception. Methods: Within the context of a South African programme to increase women\u27s access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article. Results: HIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59; p=0.7). Conclusions: This sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision

Zika virus infection in pregnant women in Honduras: study protocol

Background: Although there is increasing evidence for a relationship between symptomatic Zika virus (ZIKV) maternal infection, and microcephaly, a firm causal relation has yet to be established by epidemiologic studies. Studies also need to be conducted in recently infected settings. Our objectives are to assess the frequency of ZIKV infection during pregnancy in Honduras and the association of microcephaly with ZIKV infection. Methods/Design: We will perform a prospective study enrolling pregnant women at their first antenatal visit and following them up until delivery. At the time of enrollment, women will be interviewed to collect socio-demographic data, data needed to locate them for potential additional follow-up, and data about ZIKV symptoms during pregnancy. We will also collect maternal blood as soon as possible after enrollment. A probable maternal ZIKV infection will be defined as positive for maternal ZIKV IgM. A confirmed maternal ZIKV infection will be defined as positive for ZIKV IgM confirmed by plaque reduction neutralization test. Microcephaly at birth will be defined as an occipito-frontal circumference <2SD for sex and gestational age. Our objective is to enroll 2000 pregnant women. In a first step, we will follow a case cohort design and only analyze blood samples for cases and a sub-cohort of 200 women randomly selected. Blood samples for the entire population will be analyzed at a later stage if funds are available. Discussion: This protocol was designed to be implemented with minimal resources. It allows a cohort to be built, which could be a foundation for future in-depth and follow-up studies.Fil: Buekens, Pierre. University of Tulane; Estados UnidosFil: Alger, Jackeline. Universidad Nacional Autónoma de Honduras; HondurasFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bustillo, Carolina. Hospital Escuela. Departamento de Ginecología y Obstetricia; HondurasFil: Cafferata, Maria Luisa. Hospital de Clínicas. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Harville, Emily. University of Tulane; Estados UnidosFil: Rosales, Karla. Región Sanitaria Metropolitana Distrito Central de Francisco Morazán; HondurasFil: Wesson, Dawn M.. University of Tulane; Estados UnidosFil: Zuniga, Concepcion. Hospital Escuela Universitario. Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal; Hondura

Treatment of Retinopathy of Prematurity with topical ketorolac tromethamine: a preliminary study

BACKGROUND: Retinopathy of Prematurity (ROP) is a common retinal neovascular disorder of premature infants. It is of variable severity, usually heals with mild or no sequelae, but may progress to blindness from retinal detachments or severe retinal scar formation. This is a preliminary report of the effectiveness and safety of a new and original use of topical ketorolac in preterm newborn to prevent the progression of ROP to the more severe forms of this disease. METHODS: From January 2001 to December 2002, all fifty nine preterm newborns with birthweight less than 1250 grams or gestational age less than 30 weeks of gestational age admitted to neonatal intensive care were eligible for treatment with topical ketorolac (0.25 milligrams every 8 hours in each eye). The historical comparison group included all 53 preterm newborns, with the same inclusion criteria, admitted between January 1999 and December 2000. RESULTS: Groups were comparable in terms of weight distribution, Apgar score at 5 minutes, incidence of sepsis, intraventricular hemorrhage and necrotizing enterocolitis. The duration of oxygen therapy was significantly longer in the control group. In the ketorolac group, among 43 children that were alive at discharge, one (2.3%) developed threshold ROP and cryotherapy was necessary. In the comparison group 35 children survived, and six child (17%) needed cryotherapy (Relative Risk 0.14, 95%CI 0.00 to 0.80, p = 0.041). Adjusting by duration of oxygen therapy did not significantly change these results. Adverse effects attributable to ketorolac were not detected. CONCLUSIONS: This preliminary report suggests that ketorolac in the form of an ophthalmic solution can reduce the risk of developing severe ROP in very preterm newborns, without producing significant adverse side effects. These results, although promising, should be interpreted with caution because of the weakness of the study design. This is an inexpensive and simple intervention that might ameliorate the progression of a disease with devastating consequences for children and their families. We believe that next logical step would be to assess the effectiveness of this intervention in a randomized controlled trial of adequate sample size

A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627]

BACKGROUND: A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples. METHODS/DESIGN: The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Background: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher. WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. Methods: This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected healthcare practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected healthcare practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. Discussion: There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country’s health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘habits’ will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study

Provision of medical supply kits to improve quality of antenatal care in Mozambique: a stepped-wedge cluster randomised trial

Background: High levels of maternal and newborn mortality and morbidity remain a daunting reality in many lowincome countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. Methods: We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Findings: Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81–1039·11; p\u3c0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29874 (97·1%) of 30772 in the intervention period (1875·18; 1447·56–2429·11; p\u3c0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70–2·09; p\u3c0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites. Interpretation: A supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies. Funding: Government of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproductio

Overweight and obesity in schoolchildren from Brandsen and its relationship with socio-environmental characteristics of residence

Introducción: Los factores socioambientales desempeñan un papel esencial en la etiología del sobrepeso (S) y la obesidad (O) y constituyen el llamado “entorno obesogénico”. Los objetivos del presente trabajo son: a) estimar las prevalencias de sobrepeso y obesidad en escolares de 3 a 14 años del partido de Brandsen (Provincia de Buenos Aires) y b) analizar la probabilidad de ocurrencia de sobrepeso y obesidad en relación a las condiciones socioambientales de residencia. Población y métodos: Se relevaron peso y talla de 989 escolares, de ambos sexos, de 3-14 años de edad. Se determinaron S y O según los criterios de la International Obesity Task Force. Las prevalencias fueron comparadas entre sexos y edades. Los datos socioambientales, obtenidos a partir de encuestas, fueron procesados mediante Análisis de Componentes Principales (catPCA). Se empleó un Modelo Lineal Generalizado (link logit) para las variables S y O. Resultados: El 15,8% de los escolares presentó S y el 7,2% O, encontrándose diferencias estadísticas no significativas entre sexos y edades. El primer eje del análisis catPCA, discriminó con valores positivos los casos que presentaron las mejores condiciones socioambientales y negativos las más desfavorables. Hubo mayor probabilidad de niños obesos asociada a condiciones socioambientales adecuadas (mayor nivel educativo de padres, mayores ingresos y mejor acceso a servicios públicos), en tanto que se observó mayor probabilidad de niños con sobrepeso asociada a ambientes menos favorecidos. Conclusiones: Se concluye que la población escolar de Brandsen presenta elevadas prevalencias de sobrepeso y obesidad. La probabilidad de presentar sobrepeso es mayor en los niños provenientes de hogares con condiciones socioambientales desfavorables. La obesidad, en cambio, lo es en aquellos hogares que reúnen condiciones socioambientales favorables.Introduction: Environmental factors play an important role in the etiology of overweight (S) and obesity (O), constituting the "obesogenic environment”. The objectives of the present study are: a) to estimate overweight and obesity prevalences in 3 to 14 years-old schoolchildren from Brandsen (Provincia de Buenos Aires), and b) to analyze the probability of occurrence of overweight and obesity in relation to the socioenvironmental conditions of resident. Population and methods: Weight and height were measured in 989 boys and girls aged 3 to 14 years. S and O were estimated following the criteria suggested by the International Obesity Task Force. The prevalences of S and O were compared between genders and ages. The socio-environmental information was gathered according to surveys and processed by Categorical Principal Components Analysis (catPCA). Generalized Linear Model (link logit) against the variables S and O was employed. Results: S was found in 15,8% of schoolchildren and O in 7,2%. None significative statistics differences between both genders and ages, were found. The first axis of the catPCA discriminated the cases that presented better socio-environmental conditions with positive values and those with more unfavorable conditions with negatives values. Higher probability of obese children was associated with better socio-environmental conditions (higher educational level of parents, higher income and better access to public services), and higher probability of overweight children was associated with less favored environments. Conclusions: The schoolchildren population of Brandsen presents high overweight and obesity prevalences. The chance of presenting overweight is higher in children from households with adverse socio-environmental conditions. On the contrary, obese children are to be more found in households which have more favorable socio-environmental conditions.Fil: Cesani Rossi, María Florencia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico CONICET- La Plata. Instituto de Genética Veterinaria "Ing. Fernando Noel Dulout". Universidad Nacional de La Plata. Facultad de Ciencias Veterinarias. Instituto de Genética Veterinaria; ArgentinaFil: Luis, María Antonia. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo; ArgentinaFil: Torres, María Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico CONICET- La Plata. Instituto de Genética Veterinaria "Ing. Fernando Noel Dulout". Universidad Nacional de La Plata. Facultad de Ciencias Veterinarias. Instituto de Genética Veterinaria; Argentina. Universidad de Buenos Aires. Facultad de Filosofía y Letras; ArgentinaFil: Castro, Luis Eduardo. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo; ArgentinaFil: Quintero, Fabian Anibal. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico CONICET- La Plata. Instituto de Genética Veterinaria "Ing. Fernando Noel Dulout". Universidad Nacional de La Plata. Facultad de Ciencias Veterinarias. Instituto de Genética Veterinaria; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo; ArgentinaFil: Luna, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico CONICET- La Plata. Instituto de Genética Veterinaria "Ing. Fernando Noel Dulout". Universidad Nacional de La Plata. Facultad de Ciencias Veterinarias. Instituto de Genética Veterinaria; ArgentinaFil: Bergel Sanchís, María Laura. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo; ArgentinaFil: Oyhenart, Evelia Edith. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico CONICET- La Plata. Instituto de Genética Veterinaria "Ing. Fernando Noel Dulout". Universidad Nacional de La Plata. Facultad de Ciencias Veterinarias. Instituto de Genética Veterinaria; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo; Argentin