Gestational Diabetes Mellitus (GDM)NCT07489456
Screening for Dysglycemia During Postpartum Period in Women With GDM
A study testing Whatsapp message in people with Gestational Diabetes Mellitus (GDM), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Whatsapp message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Mar 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:
- initial fasting blood glucose ≥ 92mg/dL OR
- 75g oral glucose tolerance test with fasting ≥ 92mg/dL or after 1h ≥ 180mg/dL or after 2h ≥ 153mg/dL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form
Who cannot join
- Withdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05.403-905
Tatiana A Zaccara, MD PhD, +551126616209, tatiana.assuncao@hc.fm.usp.br
About this study
Official title: Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria
Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).
Read the detailed description
Gestational diabetes is one of the most common complications during pregnancy. With the increase in obesity and overweight in the population, as well as the postponement of motherhood, its incidence has been steadily increasing.
It is associated with complications such as polyhydramnios, macrosomia, premature labor, fetal death, hypoglycemia, and neonatal respiratory distress. Given the increase in the incidence of gestational diabetes and its clinical and epidemiological importance, a better understanding of the disease can promote improved care and prevention of its complications.
Women diagnosed with gestational diabetes mellitus (GDM) are at increased risk of developing prediabetes and type 2 diabetes in the years following childbirth. For this reason, national and international guidelines recommend performing a 75g oral glucose tolerance test (OGTT-75g) in the postpartum period, usually between six and 12 weeks after delivery, as a strategy for reclassifying glycemic status and early identification of persistent metabolic changes.
Despite the clinical relevance of the OGTT-75g in the follow-up of women with GDM, the rate of attendance for the test is notoriously low, especially in public health services. The reasons are multifactorial and include task overload in the postpartum period, logistical barriers, low risk perception, and the absence of systematic strategies to reinforce attendance. Simple interventions, such as sending reminders via electronic messages, have shown promise.
Considering the clinical and epidemiological relevance of GDM and these two complementary challenges-low attendance rates for screening and the diagnostic limitations of the current protocol-we propose two lines of investigation in this study:
- to evaluate the impact of sending reminders via WhatsApp on the return rate for performing the 75g OGTT in the postpartum period; and
- to compare the prevalence of glycemic changes identified by two different diagnostic strategies: the traditional one (fasting and two-hour blood glucose) and the new one (fasting and one-hour blood glucose). The results obtained may contribute to the qualification of care protocols and the prevention of adverse metabolic outcomes in women with a history of GDM.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Whatsapp message
- Keywords
- dysglycemia, gestational diabetes, prediabetes, diabetes, postpartum OGTT
- Medical subject headings
- Diabetes, Gestational, Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whatsapp messageOther
Automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group (current practice): will not receive reminder messages for the exam. |
| Intervention group | Experimental | Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D for sending reminder messages. Receives: Other: Whatsapp message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that attend to the postpartum OGTT
Impact of electronic messages in the attendance rate of postpartum women with GDM at the TOTG-75g exam between 6 and 12 weeks after delivery
Measured: From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)
Secondary outcomes (1)
Dysglycemia rate according to diagnostic set of criteria
Compare the prevalence of prediabetes and diabetes in the postpartum period according to two diagnostic strategies applied to the 75g OGTT:
Strategy A (currently in use): fasting blood glucose measurements and measurements two hours after glucose loading Strategy B (under investigation): fasting blood glucose measurements and measurements one hour after glucose loading
Measured: From enrollment to OGTT test (6 to 12 weeks after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start24 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label clinical trial with two parallel groups, aiming to evaluate the effect of sending reminder messages via institutional WhatsApp on the attendance rate at TOTG-75g in the postpartum period. Eligible participants will be randomly allocated, using a computer-generated sequence, into two groups: Control Group (current practice): will not receive reminder messages for the exam. Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Assunção Zaccara, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489456
- Sponsor's protocol ID
- 95734326.5.0000.0068
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milluzzo A, Manuella L, Frittitta L, Sciacca L. Efficacy of a phone reminder to improve adherence to post-partum glucose tolerance testing after gestational diabetes and clinical predictors of post-partum follow-up compliance. Diabetes Res Clin Pract. 2024 Apr;210:111653. doi: 10.1016/j.diabres.2024.111653. Epub 2024 Apr 2.
PubMed 38574892Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Diabetes Care. 2025 Jun 1;48(6):874-876. doi: 10.2337/dci25-0021. No abstract available.
PubMed 40392998Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Diabetes Metab. 2022 Nov;48(6):101395. doi: 10.1016/j.diabet.2022.101395. Epub 2022 Sep 29.
PubMed 36184047Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, Zinman B. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-895. doi: 10.2337/dc24-1848.
PubMed 40029070McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Int J Environ Res Public Health. 2022 Dec 15;19(24):16827. doi: 10.3390/ijerph192416827.
PubMed 36554709Bozkurt L, Gobl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, Baumgartner-Parzer S, Pacini G, Kautzky-Willer A. Pathophysiological characteristics and effects of obesity in women with early and late manifestation of gestational diabetes diagnosed by the International Association of Diabetes and Pregnancy Study Groups criteria. J Clin Endocrinol Metab. 2015 Mar;100(3):1113-20. doi: 10.1210/jc.2014-4055. Epub 2015 Jan 9.
PubMed 25574889Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, Cabero Roura L, McIntyre HD, Morris JL, Divakar H. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 3:S173-211. doi: 10.1016/S0020-7292(15)30033-3. No abstract available.
PubMed 26433807
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria
- ClinicalTrials.gov ID
- NCT07489456
- Acronym / sponsor ID
- 95734326.5.0000.0068
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- dysglycemia, gestational diabetes, prediabetes, diabetes, postpartum OGTT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Mar 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.
Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).
Detailed description
Gestational diabetes is one of the most common complications during pregnancy. With the increase in obesity and overweight in the population, as well as the postponement of motherhood, its incidence has been steadily increasing.
It is associated with complications such as polyhydramnios, macrosomia, premature labor, fetal death, hypoglycemia, and neonatal respiratory distress. Given the increase in the incidence of gestational diabetes and its clinical and epidemiological importance, a better understanding of the disease can promote improved care and prevention of its complications.
Women diagnosed with gestational diabetes mellitus (GDM) are at increased risk of developing prediabetes and type 2 diabetes in the years following childbirth. For this reason, national and international guidelines recommend performing a 75g oral glucose tolerance test (OGTT-75g) in the postpartum period, usually between six and 12 weeks after delivery, as a strategy for reclassifying glycemic status and early identification of persistent metabolic changes.
Despite the clinical relevance of the OGTT-75g in the follow-up of women with GDM, the rate of attendance for the test is notoriously low, especially in public health services. The reasons are multifactorial and include task overload in the postpartum period, logistical barriers, low risk perception, and the absence of systematic strategies to reinforce attendance. Simple interventions, such as sending reminders via electronic messages, have shown promise.
Considering the clinical and epidemiological relevance of GDM and these two complementary challenges-low attendance rates for screening and the diagnostic limitations of the current protocol-we propose two lines of investigation in this study:
- to evaluate the impact of sending reminders via WhatsApp on the return rate for performing the 75g OGTT in the postpartum period; and
- to compare the prevalence of glycemic changes identified by two different diagnostic strategies: the traditional one (fasting and two-hour blood glucose) and the new one (fasting and one-hour blood glucose). The results obtained may contribute to the qualification of care protocols and the prevention of adverse metabolic outcomes in women with a history of GDM.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label clinical trial with two parallel groups, aiming to evaluate the effect of sending reminder messages via institutional WhatsApp on the attendance rate at TOTG-75g in the postpartum period. Eligible participants will be randomly allocated, using a computer-generated sequence, into two groups: Control Group (current practice): will not receive reminder messages for the exam. Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group (current practice): will not receive reminder messages for the exam. |
| Intervention group | Experimental | Other: Whatsapp messageIntervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D for sending reminder messages. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:
- initial fasting blood glucose ≥ 92mg/dL OR
- 75g oral glucose tolerance test with fasting ≥ 92mg/dL or after 1h ≥ 180mg/dL or after 2h ≥ 153mg/dL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form
Key exclusion criteria (1 listed)
- Withdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)
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 |
|---|---|---|
| Whatsapp messageAutomatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. | Other | Intervention group |
Primary outcome
Number of patients that attend to the postpartum OGTT
Time frame: From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)
Impact of electronic messages in the attendance rate of postpartum women with GDM at the TOTG-75g exam between 6 and 12 weeks after delivery
1 secondary outcome
Dysglycemia rate according to diagnostic set of criteria
Time frame: From enrollment to OGTT test (6 to 12 weeks after delivery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 38574892Milluzzo A, Manuella L, Frittitta L, Sciacca L. Efficacy of a phone reminder to improve adherence to post-partum glucose tolerance testing after gestational diabetes and clinical predictors of post-partum follow-up compliance. Diabetes Res Clin Pract. 2024 Apr;210:111653. doi: 10.1016/j.diabres.2024.111653. Epub 2024 Apr 2.
- Background: PubMed 40392998Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Diabetes Care. 2025 Jun 1;48(6):874-876. doi: 10.2337/dci25-0021. No abstract available.
- Background: PubMed 36184047Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Diabetes Metab. 2022 Nov;48(6):101395. doi: 10.1016/j.diabet.2022.101395. Epub 2022 Sep 29.
- Background: PubMed 40029070Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, Zinman B. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-895. doi: 10.2337/dc24-1848.
- Background: PubMed 36554709McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Int J Environ Res Public Health. 2022 Dec 15;19(24):16827. doi: 10.3390/ijerph192416827.
- Background: PubMed 25574889Bozkurt L, Gobl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, Baumgartner-Parzer S, Pacini G, Kautzky-Willer A. Pathophysiological characteristics and effects of obesity in women with early and late manifestation of gestational diabetes diagnosed by the International Association of Diabetes and Pregnancy Study Groups criteria. J Clin Endocrinol Metab. 2015 Mar;100(3):1113-20. doi: 10.1210/jc.2014-4055. Epub 2015 Jan 9.
- Background: PubMed 26433807Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, Cabero Roura L, McIntyre HD, Morris JL, Divakar H. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 3:S173-211. doi: 10.1016/S0020-7292(15)30033-3. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whatsapp message in people with Gestational Diabetes Mellitus (GDM), run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 May 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana A Zaccara, MD PhD (+551126616209, tatiana.assuncao@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that attend to the postpartum OGTT (time frame: From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)). 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 NCT07489456, which also lists 7 linked publications.
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 4 May 2026.