Rationale and Design of Khuzestan Vitamin D Deficiency Screening Program in Pregnancy: A Stratified Randomized Vitamin D Supplementation Controlled Trial
Notice bibliographique
Résumé
BACKGROUND: Although there have been marked improvements in our understanding of vitamin D functions in different diseases, gaps on its role during pregnancy remain. Due to the lack of consensus on the most accurate marker of vitamin D deficiency during pregnancy and the optimal level of 25-hydroxyvitamin D, 25(OH)D, for its definition, vitamin D deficiency assessment during pregnancy is a complicated process. Besides, the optimal protocol for treatment of hypovitaminosis D and its effect on maternal and neonatal outcomes are still unclear. OBJECTIVE: The aim of our study was to estimate the prevalence of vitamin D deficiency in the first trimester of pregnancy and to compare vitamin D screening strategy with no screening. Also, we intended to compare the effectiveness of various treatment regimens on maternal and neonatal outcomes in Masjed-Soleyman and Shushtar cities of Khuzestan province, Iran. METHODS: This was a two-phase study. First, a population-based cross-sectional study was conducted; recruiting 1600 and 900 first trimester pregnant women from health centers of Masjed-Soleyman and Shushtar, respectively, using stratified multistage cluster sampling with probability proportional to size (PPS) method. Second, to assess the effect of screening strategy on maternal and neonatal outcomes, Masjed-Soleyman participants were assigned to a screening program versus Shushtar participants who became the nonscreening arm. Within the framework of the screening regimen, an 8-arm blind randomized clinical trial was undertaken to compare the effects of various treatment protocols. A total of 800 pregnant women with vitamin D deficiency were selected using simple random sampling from the 1600 individuals of Masjed-Soleyman as interventional groups. Serum concentrations of 25(OH)D were classified as: (1) severe deficient (<10ng/ml), (2) moderate deficient (10-20ng/ml), and (3) normal status (>20ng/ml). Those with severe and moderate deficiency were randomly divided into 4 subgroups and received vitamin D3 based on protocol and were followed until delivery. Data was analyzed according to the intention-to-treat principle. RESULTS: Recruitment commenced in July, 2014, and as estimated, nearly 3.5 years is needed to complete the study. Results of this study will (1) provide reliable information regarding the prevalence of vitamin D deficiency during pregnancy using universal vitamin D screening approach and (2) determine the beneficial effects of universal screening and compare the various treatment protocols in terms of pregnancy outcomes. CONCLUSIONS: Since vitamin D deficiency is a prevalent disorder in pregnancy among Iranian population, this study will ensure creation of reliable evidence-based findings and will enable clinicians to better evaluate and treat vitamin D deficient pregnant women. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 2014102519660N1; http://www.irct.ir/searchresult.php?keyword=&id=19660&number=1&prt=7805&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6p3lkqFdV).
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,030 | 0,024 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,002 |
| Méta-épidémiologie (sens large) | 0,010 | 0,005 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,002 | 0,003 |
| Communication savante | 0,003 | 0,002 |
| Science ouverte | 0,003 | 0,001 |
| Intégrité de la recherche | 0,006 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,023 | 0,004 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».