NCT07731165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.9 years

First QC Date

July 14, 2026

Last Update Submit

July 27, 2026

Conditions

Small Gestational Age (SGA)Hypoglycemia After Gastric BypassGlycemic Variability

Keywords

bariatric surgerysmall-for-gestational-age neonatesglycemic variabilitycontinuous glucose monitoringhypoglycemiapregnancy

Outcome Measures

Primary Outcomes (2)

  • Birth weight

    Birth weight measured in grams

    At delivery (up to 41 gestational weeks)

  • Mean absolute glucose change [MAG change]

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

    During two weeks - once per trimester of pregnancy

Study Arms (1)

Pregnant women post- bariatric surgery - Characterization of the glucose profile and birth weight

OTHER

Pregnant women previously submitted to metabolic bariatric surgery underwent intermittently scanned continuous glucose monitoring once per trimester (14 days).

Device: Intermittently Scanned Continuous Glucose Monitoring (isCGM)

Interventions

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.

Pregnant women post- bariatric surgery - Characterization of the glucose profile and birth weight

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women who underwent metabolic bariatric surgery
  • Enrollement at first or second trimesters of pregnancy

You may not qualify if:

  • Twin pregnancies
  • Pregnancies ending in miscarriage
  • Pregnancies with planned delivery at other institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUStAntónio - Centro Materno Infantil Norte (CMIN)

Porto, Porto District, 4050-651, Portugal

Location

Related Publications (1)

  • Lobato CB, Pereira SS, Guimaraes M, Morais T, Oliveira P, de Carvalho JPM, Nora M, Monteiro MP. Use of flash glucose monitoring for post-bariatric hypoglycaemia diagnosis and management. Sci Rep. 2020 Jul 6;10(1):11061. doi: 10.1038/s41598-020-68029-8.

    PMID: 32632211BACKGROUND

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 28, 2026

Study Start

January 26, 2021

Primary Completion

December 31, 2023

Study Completion

September 30, 2025

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)