Achieving Optimal Gestational Weight Gain, Birth Weight, and Perinatal Outcomes Among Pregnant Women at Risk of Hypertension: Protocol for a Pilot Randomized Controlled Trial
Notice bibliographique
Résumé
BACKGROUND: Hypertensive disorders, including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive disorders. Conventional antenatal care practices often delay or miss detecting hypertensive disorders in pregnancy, which may allow some women to become vulnerable to the adverse consequences of the hypertensive disorders. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; however, to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined. OBJECTIVE: The objectives of this study are to evaluate the accuracy of a wearable blood pressure monitoring device (Health Gauge) in order to test the design and methods of a future definitive randomized controlled trial, and to examine the feasibility, acceptability, and fidelity of an intervention focusing on regular monitoring of weight gain and self-monitoring of blood pressure for pregnant women at risk of developing hypertensive disorders and their associated complications. METHODS: The study is located in Matlab, Bangladesh will be conducted in two phases. First, a wearable blood pressure device (Health Gauge) will be validated in accordance with the European Society of Hypertension International Protocol (revision 2010). Second, a prospective, two-arm, parallel, and nonblinded randomized controlled external pilot trial will be conducted. In the pilot trial, 70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment). All women will receive standard antenatal care. RESULTS: A validation study of the wearable blood pressure device has successfully been conducted among the general adult population in Matlab, Bangladesh. As of September 2019, the pilot trial has completed enrollment of women who are pregnant (N=70; intervention: n=35; control: n=35) and follow-up of the participants is ongoing. Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020. CONCLUSIONS: The findings of this study will help us to design a comprehensive, full-scale randomized controlled trial to test the efficacy of regular self-monitoring of blood pressure and weight gain during pregnancy, a simple and inexpensive intervention to help to achieve optimal maternal and fetal outcomes in pregnant women at risk of developing hypertensive disorders and their associated complications during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16676.
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 | 0,055 | 0,046 |
| Méta-épidémiologie (sens strict) | 0,007 | 0,004 |
| Méta-épidémiologie (sens large) | 0,013 | 0,007 |
| Bibliométrie | 0,003 | 0,004 |
| Études des sciences et des technologies | 0,004 | 0,005 |
| Communication savante | 0,005 | 0,004 |
| Science ouverte | 0,005 | 0,003 |
| Intégrité de la recherche | 0,008 | 0,009 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,069 | 0,011 |
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 ».