Glycemic Variability During Pregnancy After 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.

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Key information

Conditions

Small Gestational Age (SGA) Glucose Metabolism Disorders Glycemic Variability Hypoglycemia Hypoglycemia After Gastric Bypass Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHUStAntónio - Centro Materno Infantil Norte (CMIN)

Porto, Porto District, 4050-651, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittently Scanned Continuous Glucose Monitoring (isCGM)

Device

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.

Primary outcomes

Birth weight

Time frame: At delivery (up to 41 gestational weeks)

Birth weight measured in grams
Mean absolute glucose change [MAG change]

Time frame: During two weeks - once per trimester of pregnancy

MAG change measures the average rate of glucose change over time, capturing both magnitude and speed. Unit: mg/dLxh-1

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Universitário de Santo António

Other

Registry information

Official study title

Glycemic Variability on Continuous Glucose Monitoring Predicts Small-for-Gestational-Age Neonates in Pregnancies After Metabolic and Bariatric Surgery

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed