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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Porto District
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Porto, Porto District, Portugal, 4050-651
- CHUStAntónio - Centro Materno Infantil Norte (CMIN)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Birth weight
Zeitfenster: 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]
Zeitfenster: 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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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Universidade do Porto
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