Small Gestational Age (SGA)NCT07731165
Glycemic Variability During Pregnancy After Bariatric Surgery
A study testing Intermittently Scanned Continuous Glucose Monitoring (isCGM) in people with Small Gestational Age (SGA) and Hypoglycemia After Gastric Bypass, run by Centro Hospitalar Universitário de Santo António at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Small Gestational Age (SGA), Hypoglycemia After Gastric Bypass, Glycemic Variability
- What is being tested?
- Intermittently Scanned Continuous Glucose Monitoring (isCGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePortugal
- Study dates
- 26 Jan 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women who underwent metabolic bariatric surgery
- Enrollement at first or second trimesters of pregnancy
Who cannot join
- Twin pregnancies
- Pregnancies ending in miscarriage
- Pregnancies with planned delivery at other institution
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CHUStAntónio - Centro Materno Infantil Norte (CMIN)
Porto, Porto District, 4050-651
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Intermittently Scanned Continuous Glucose Monitoring (isCGM)
- Keywords
- bariatric surgery, small-for-gestational-age neonates, glycemic variability, continuous glucose monitoring, hypoglycemia, pregnancy
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Intermittently Scanned Continuous Glucose Monitoring (isCGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Birth weight measured in grams
Measured: 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
Measured: During two weeks - once per trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start26 Jan 2021
- Primary completion31 Dec 2023
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Gestational Age (SGA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário de Santo António
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Rodrigues dos Santos Martins, Centro Hospitalar Universitário de Santo António
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731165
- Sponsor's protocol ID
- Universidade do Porto
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32632211
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Variability on Continuous Glucose Monitoring Predicts Small-for-Gestational-Age Neonates in Pregnancies After Metabolic and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07731165
- Acronym / sponsor ID
- Universidade do Porto
- Keywords
- bariatric surgery, small-for-gestational-age neonates, glycemic variability, continuous glucose monitoring, hypoglycemia, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centro Hospitalar Universitário de Santo AntónioUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women post- bariatric surgery - Characterization of the glucose profile and birth weight | Other | Device: Intermittently Scanned Continuous Glucose Monitoring (isCGM)Pregnant women previously submitted to metabolic bariatric surgery underwent intermittently scanned continuous glucose monitoring once per trimester (14 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women who underwent metabolic bariatric surgery
- Enrollement at first or second trimesters of pregnancy
Key exclusion criteria (3 listed)
- Twin pregnancies
- Pregnancies ending in miscarriage
- Pregnancies with planned delivery at other institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Pregnant women post- bariatric surgery - Characterization of the glucose profile and birth weight |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 32632211Lobato 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.
- Individual participant dataSharing planned: No
Related trials for Small Gestational Age (SGA)
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Short Stature Children Born Small for Gestational Age (SGA)
Not yet recruitingPhase 3
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
Small for Gestational Age
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
Active, not recruitingPhase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
SGA, Turner Syndrome, Noonan Syndrome, ISS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittently Scanned Continuous Glucose Monitoring (isCGM) in people with Small Gestational Age (SGA) and Hypoglycemia After Gastric Bypass, run by Centro Hospitalar Universitário de Santo António at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: At delivery (up to 41 gestational weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07731165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.