Glycemic Variability During Pregnancy After Bariatric Surgery
Glycemic Variability on Continuous Glucose Monitoring Predicts Small-for-Gestational-Age Neonates in Pregnancies After Metabolic and Bariatric Surgery
Pregnancies after Metabolic and Bariatric Surgery (MBS) are linked to increased incidence of small-for-gestational-age (SGA) neonates. Hypoglycemia and glucose variability (GV) are known determinants of fetal growth; however, their impact on neonatal birth weight in pregnancies after MBS remains unclear.
This study aims to assess whether glycemic profiles in these pregnancies are associated with fetal growth and to determine if specific GV parameters can predict growth restriction and SGA neonates.
This is a single-center prospective cohort study of pregnant women previously post-MBS who underwent intermittently scanned continuous glucose monitoring (isCGM) once for trimester of pregnancy, allowing their glycemic profile to be analyzed.
The primary aims of this study were to evaluate the extent to which the glycemic profile of pregnant women after MBS impacts fetal growth, and to identify which specific GV parameters may be used to predict fetal growth restriction and SGA neonates.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Prespecified clinical data for both participants and their newborns were collected from electronic medical records - neonates were then classified as appropriate-for-gestational-age (AGA) or small-for-gestational- age (SGA).
The glucose sensors were placed by the clinical team during the appointments in the back of the arm, and participants were trained on the appropriate use of the devices.
All women were followed up by a multidisciplinary antenatal care team comprising obstetricians, endocrinologists, and dietitians. Standard pregnancy management included regular outpatient appointments for clinical follow-up and laboratory assessments of nutritional status.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Porto District
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Porto, Porto District, Le Portugal, 4050-651
- CHUStAntónio - Centro Materno Infantil Norte (CMIN)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Pregnant women who underwent metabolic bariatric surgery
- Enrollement at first or second trimesters of pregnancy
Exclusion Criteria:
- Twin pregnancies
- Pregnancies ending in miscarriage
- Pregnancies with planned delivery at other institution
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Pregnant women post- bariatric surgery - Characterization of the glucose profile and birth weight
Pregnant women previously submitted to metabolic bariatric surgery underwent intermittently scanned continuous glucose monitoring once per trimester (14 days).
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A prospective study to evaluate glycemic variability (GV) throughout pregnancy in women who have undergone bariatric surgery and its ability to predict the birth of infants small-for-gestational age (SGA).
In addition to the use of intermittently icanned continuous glucose monitoring (isCGM) a publicly accessible, automated analysis tools were employed, allowing for a more comprehensive analysis than those previously conducted.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Birth weight
Délai: At delivery (up to 41 gestational weeks)
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Birth weight measured in grams
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At delivery (up to 41 gestational weeks)
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Mean absolute glucose change [MAG change]
Délai: During two weeks - once per trimester of pregnancy
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MAG change measures the average rate of glucose change over time, capturing both magnitude and speed.
Unit: mg/dLxh-1
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During two weeks - once per trimester of pregnancy
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Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Universidade do Porto
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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