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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07731165
Enrollment
47
Registered
2026-07-28
Start date
2021-01-26
Completion date
2025-09-30
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Variability, Hypoglycemia After Gastric Bypass, Small Gestational Age (SGA)

Keywords

bariatric surgery, small-for-gestational-age neonates, glycemic variability, continuous glucose monitoring, hypoglycemia, pregnancy

Brief summary

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.

Detailed description

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.

Interventions

DEVICEIntermittently Scanned Continuous Glucose Monitoring (isCGM)

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.

Sponsors

Centro Hospitalar Universitário de Santo António
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Birth weightAt delivery (up to 41 gestational weeks)Birth weight measured in grams
Mean absolute glucose change [MAG change]During two weeks - once per trimester of pregnancyMAG change measures the average rate of glucose change over time, capturing both magnitude and speed. Unit: mg/dLxh-1

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026