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Glycemic Variability During Pregnancy After Bariatric Surgery

NCT07731165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Intermittently 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 & Collaborators

  • Centro Hospitalar Universitário de Santo António

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2023-12-31
Completion
2025-09-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731165 on ClinicalTrials.gov