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Effect of vitamin D replacement on maternal and neonatal outcomes: a randomised controlled trial in pregnant women with hypovitaminosis D. A protocol.

ABSTRACT: The vitamin D recommended doses during pregnancy differ between societies. The WHO guidelines do not recommend routine prenatal supplementation, but they underscore the fact that women with the lowest levels may benefit most. The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent. Our hypothesis is that in Middle Eastern pregnant women, a vitamin D dose of 3000 IU/day is required to reach a desirable maternal 25-hydroxyvitamin D [25(OH)D] level, and to positively impact infant bone mineral content (BMC).This is a multicentre blinded randomised controlled trial. Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached. Eligible women will be randomised to daily equivalent doses of cholecalciferol, 600 IU or 3000 IU, from 15 to 18 weeks gestation until delivery. Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery. Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month. A sample size of 280 pregnant women is needed to demonstrate a statistically significant difference in the proportion of women reaching a 25(OH)D level ≥ 50 nmol/L at delivery, and a difference in infant BMC of 6 (10)g, for a 90% power and a 2.5% level of significance. The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using χ(2). An independent t test will be used to compare mean infant BMC between the two arms. The primary analysis is an intention-to-treat analysis of unadjusted results.The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22). The trial results will be published in peer-reviewed medical journals and presented at scientific conferences.NCT02434380.

SUBMITTER: Chakhtoura M

PROVIDER: S-EPMC4785305 | biostudies-other | 2016 Mar

REPOSITORIES: biostudies-other

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Project description:Background Pregnant women with underlying heart disease ( HD ) are at increased risk for adverse maternal, obstetric, and neonatal outcomes. Methods and Results Inpatient maternal delivery admissions and linked neonatal stays for women with cardiomyopathy, adult congenital HD, pulmonary hypertension ( PH ), and valvular HD were explored utilizing the Statewide Planning and Research Cooperative System (New York), January 1, 2000, through December 31, 2014, with the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Maternal major adverse cardiac events, neonatal adverse clinical events ( NACE ), and obstetric complications were recorded. Outcomes were compared using multiple logistic regression modeling. Among 2 284 044 delivery admissions, 3871 women had HD ; 676 (17%) had cardiomyopathy, 1528 (40%) had valvular HD, 1367 (35%) had adult congenital HD, and 300 (8%) had PH . Major adverse cardiac events occurred in 16.1% of women with HD , with most in the cardiomyopathy (45.9%) and PH (25%) groups. NACE was more common in offspring of women with HD (18.4% versus 7.1%), with most in the cardiomyopathy (30.0%) and PH (25.0%) groups. Increased risk of NACE was noted for women with HD (odds ratio [ OR ]: 2.8; 95% confidence interval [ CI ], 2.5-3.0), with the highest risk for those with cardiomyopathy ( OR : 5.9; 95% CI , 5.0-7.0) and PH ( OR : 4.5; 95% CI , 3.4-5.9). Preeclampsia ( OR : 5.1; 95% CI , 3.0-8.6), major adverse cardiac events ( OR : 2.3; 95% CI , 1.8-2.9), preexisting diabetes mellitus ( OR : 4.3; 95% CI , 1.5-12.3), and obstetric complications ( OR : 2.9; 95% CI , 1.7-5.2) were independently associated with higher NACE risk. Conclusions Neonatal complications were higher in offspring of pregnant women with HD , particularly cardiomyopathy and PH . Preeclampsia, major adverse cardiac events, obstetric complications, and preexisting diabetes mellitus were independently associated with a higher risk of NACE .

Project description:BackgroundVitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D3 supplementation may improve the health of HIV-infected pregnant women and their children.Methods/designThe Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12-27 weeks gestation are randomized to either: 1) 3000 IU vitamin D3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes.DiscussionThe ToV5 will provide causal evidence on the effect of vitamin D3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach.Trial registrationClinicalTrials.gov identifier: NCT02305927 . Registered on 29 October 2014.

Project description:IntroductionWomen with metabolic risk factors are at higher risk of adverse pregnancy outcomes. Mediterranean-based dietary interventions have the potential to minimise these risks. We aim to evaluate the effectiveness of a simple, targeted intervention modelled on Mediterranean diet in preventing maternal and fetal complications in pregnant women with metabolic risk factors.Methods and analysisPregnant women with a singleton pregnancy <18 weeks gestation, and without pre-existing diabetes, chronic renal disease and autoimmune diseases will be recruited. Women with metabolic risk factors will be randomised to receive a dietary intervention based on a Mediterranean pattern, supplemented with extra virgin olive oil and mixed nuts until delivery. The intervention will be delivered through a series of one to one and group sessions. The primary outcome is a composite maternal outcome of pre-eclampsia or gestational diabetes and a composite fetal outcome of stillbirth, small for gestational age fetus or admission to the neonatal intensive care unit. Secondary outcomes include maternal, fetal, dietary and laboratory outcomes. We aim to randomise 1230 eligible women with metabolic risk factors. We will also compare the outcomes in women with and without these risk factors. The sample size will provide us with 80% power at 5% significance, assuming a 20% loss to follow-up to detect a 30% reduction in maternal and fetal complications.Ethics and disseminationThe ESTEEM trial is designed to provide a definitive estimate of the effects of Mediterranean dietary pattern in pregnancy on maternal and fetal outcomes. The pragmatic nature of ESTEEM ensures the applicability of its findings into clinical practice. The findings of the study will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the NHS Research Ethics Committees (14/EE/1048).Trial registration numberNCT02218931; Pre-results.

Project description:BackgroundMaternal obesity is associated with increased birthweight, and obesity and premature mortality in adult offspring. The mechanism by which maternal obesity leads to these outcomes is not well understood, but maternal hyperglycaemia and insulin resistance are both implicated. We aimed to establish whether the insulin sensitising drug metformin improves maternal and fetal outcomes in obese pregnant women without diabetes.MethodsWe did this randomised, double-blind, placebo-controlled trial in antenatal clinics at 15 National Health Service hospitals in the UK. Pregnant women (aged ≥16 years) between 12 and 16 weeks' gestation who had a BMI of 30 kg/m(2) or more and normal glucose tolerance were randomly assigned (1:1), via a web-based computer-generated block randomisation procedure (block size of two to four), to receive oral metformin 500 mg (increasing to a maximum of 2500 mg) or matched placebo daily from between 12 and 16 weeks' gestation until delivery of the baby. Randomisation was stratified by study site and BMI band (30-39 vs ≥40 kg/m(2)). Participants, caregivers, and study personnel were masked to treatment assignment. The primary outcome was Z score corresponding to the gestational age, parity, and sex-standardised birthweight percentile of liveborn babies delivered at 24 weeks or more of gestation. We did analysis by modified intention to treat. This trial is registered, ISRCTN number 51279843.FindingsBetween Feb 3, 2011, and Jan 16, 2014, inclusive, we randomly assigned 449 women to either placebo (n=223) or metformin (n=226), of whom 434 (97%) were included in the final modified intention-to-treat analysis. Mean birthweight at delivery was 3463 g (SD 660) in the placebo group and 3462 g (548) in the metformin group. The estimated effect size of metformin on the primary outcome was non-significant (adjusted mean difference -0·029, 95% CI -0·217 to 0·158; p=0·7597). The difference in the number of women reporting the combined adverse outcome of miscarriage, termination of pregnancy, stillbirth, or neonatal death in the metformin group (n=7) versus the placebo group (n=2) was not significant (odds ratio 3·60, 95% CI 0·74-17·50; p=0·11).InterpretationMetformin has no significant effect on birthweight percentile in obese pregnant women. Further follow-up of babies born to mothers in the EMPOWaR study will identify longer-term outcomes of metformin in this population; in the meantime, metformin should not be used to improve pregnancy outcomes in obese women without diabetes.FundingThe Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research partnership.

Project description:BackgroundVitamin D deficiency has been linked to poor outcomes after total hip replacement (THR) or total knee replacement (TKR), including lower patient-reported outcome measures (PROMs), peri-prosthetic infection and longer hospital stay. We present a randomised feasibility trial protocol designed to prospectively investigate the influence of vitamin D testing, and subsequent supplementation for deficiency, prior to THR/TKR.Methods/designOne hundred adult patients undergoing primary THR/TKR for osteoarthritis at two NHS hospital trusts in North East England will be recruited. Exclusion criteria include lack of mental capacity, revision surgery, participants already taking vitamin D/calcium supplements, or a known contraindication to vitamin D treatment. Participants will be ineligible for the trial if they have an estimated glomerular filtration rate < 30 ml/minute. We will measure patients' vitamin D levels at baseline, and those identified as deficient (vitamin D < 50 nmol/L) will be randomised to receive either vitamin D supplementation or no supplementation prior to, and for 6 months following, surgery. Patients with a normal vitamin D level (≥50 nmol/L) will receive no supplementation. Vitamin D levels will be rechecked on the day of surgery and again at 6 months. Patients will also complete a lifestyle questionnaire, as well as the Oxford hip or knee and EQ-5D-3 L PROM questionnaires, at baseline and at 6 months following surgery. The aims are to determine the feasibility of the methodology and to gather data to inform the conduct of a future, larger trial to investigate if supplementation with vitamin D, in those who are deficient, prior to THR/TKR improves outcomes as measured by PROM scores.DiscussionPrevious reports have measured vitamin D levels and correlated this to outcome, but we can find no randomised trial in which researchers investigated the effect of supplementation. The aim of this trial is to determine if vitamin D deficiency is a modifiable risk factor for poor outcome after THR/TKR.Trial registrationISRCTN Registry, ISRCTN14533082 . Registered on 3 April 2017.

Project description:ImportanceWomen with disabilities have a higher risk of preterm birth, gestational diabetes, preeclampsia, and cesarean delivery; however, their risk of other obstetric interventions, adverse maternal outcomes, and clinical indications for increased cesarean delivery is unclear.ObjectiveTo evaluate risk of a range of obstetric interventions and adverse maternal outcomes, including severe maternal morbidities (SMM) and mortality, among women with and without disabilities.Design, setting, and participantsThe Consortium on Safe Labor was a retrospective cohort that included comprehensive medical chart review for deliveries between January 2002 and January 2008. Data were collected from 12 clinical sites, which included 19 hospitals across the United States. This secondary analysis was conducted in February to July 2021.ExposuresUsing International Classification of Diseases, Ninth Revision, codes and a validated algorithm to define disability, participants were classified as having physical, intellectual, sensory, or any disability, and compared with women with no documented disability.Main outcomes and measuresThe relative risk (RR) of 23 obstetric interventions and adverse maternal outcomes, including SMM and mortality, was evaluated.ResultsOf the 223 385 women in the study, 9206 (4.1%) were Asian or Pacific Islander, 50 235 (22.5%) were Black, 39 039 (17.5%) were Hispanic, and 110 443 (49.4%) were White, with a mean (SD) age of 27.6 (6.2) years. There were 2074 (0.9%) women with disability and 221 311 (99.1%) without. Among women with disabilities, 1733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. Compared with women with no disability, women with disabilities had higher risk of gestational diabetes, placenta previa, premature rupture of membranes, preterm premature rupture of membranes, and postpartum fever as well as maternal death (adjusted relative risk [aRR], 11.19; 95% CI, 2.40-52.19) and individual SMMs: severe preeclampsia/eclampsia (aRR, 2.15; 95% CI, 1.80-2.56), hemorrhage (aRR, 1.27; 95% CI, 1.09-1.49), and fever (aRR, 1.32; 95% CI, 1.03-1.67), with the highest risk observed for thromboembolism (aRR, 6.08; 95% CI, 4.03-9.16), cardiovascular events (aRR, 4.02; 95% CI, 2.87-5.63), and infection (aRR, 2.69; 95% CI, 1.97-3.67). Women with any disability also had higher risk of interventions, including oxytocin augmentation, operative vaginal delivery, and cesarean delivery (aRR, 1.33; 95% CI, 1.25-1.42), with the cesarean indication less likely to be medically indicated (aRR, 0.79; 95% CI, 0.70-0.89). Risk of adverse outcomes and interventions remained consistent across disability categories.Conclusions and relevanceIn this study, women with physical, intellectual, and sensory disability during pregnancy were at higher risk of adverse outcomes, including a broad range of SMM and maternal mortality.

Project description:BackgroundThe achievement of target 25-hydroxyvitamin D [25(OH)D] concentrations in pregnancy may be altered by maternal obesity.ObjectiveThe authors examined the effects of maternal supplementation of 10 μg compared with 20 μg vitamin D3/d on maternal and umbilical cord 25(OH)D. The secondary aim was to investigate the influence of maternal BMI (in kg/m2) on the response of the primary outcomes.MethodsThe authors performed a 2-arm parallel double-blind randomized trial with 240 pregnant women recruited throughout the year in Northern Ireland. Women were stratified by BMI to receive 10 or 20 µg vitamin D3/d from 12 gestational wk (GW) until delivery. Maternal blood samples collected at 12, 28, and 36 GW and from the umbilical cord were analyzed for total serum 25(OH)D. A total of 166 women completed the study.ResultsMean ± SD 25(OH)D at 36 GW was 80.8 ± 28.2 compared with 94.4 ± 33.2 nmol/L (P < 0.001) (10 compared with 20 µg vitamin D3/d, respectively). In those classified with 25(OH)D <50 nmol/L at baseline and assigned 10 µg vitamin D3/d, mean 25(OH)D concentrations remained <50 nmol/L at 36 GW, whereas those <50 nmol/L at baseline and assigned 20 µg vitamin D3/d, had mean 25(OH)D concentrations ≥50 nmol/L at 28 and 36 GW. In women with obesity and 25(OH)D <50 nmol/L at baseline, the related mean umbilical cord 25(OH)D was deficient (<25 nmol/L) in both treatment groups, whereas those with obesity and 25(OH)D ≥50 nmol/L at baseline had an average umbilical cord 25(OH)D between 25 and 50 nmol/L in both treatment groups.ConclusionsSupplementation of 20 µg vitamin D3/d is needed to attain maternal and umbilical cord 25(OH)D concentrations ≥50 nmol/L on average, in those who start pregnancy with low 25(OH)D concentrations (<50 nmol/L). Under current recommendations, women with obesity and low 25(OH)D in early pregnancy are particularly vulnerable to maintaining a low 25(OH)D concentration throughout pregnancy and having an infant born with deficient 25(OH)D concentrations. This trial was registered at ClinicalTrials.gov as NCT02713009.

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Effect of vitamin D replacement on maternal and neonatal outcomes: a randomised controlled trial in pregnant women with hypovitaminosis D. A protocol.

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