Postpartum Diabetes Screening for Gestational Diabetes

Overseen By Kartik Venkatesh, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Gastric bypass, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for screening diabetes immediately after childbirth in individuals who had gestational diabetes, a type of diabetes that develops during pregnancy. The study compares an immediate inpatient postpartum OGTT (Oral Glucose Tolerance Test) in the hospital before discharge to the usual method of testing weeks later. The goal is to determine if earlier testing can more effectively detect diabetes. The trial seeks participants who have just given birth, had gestational diabetes, and can speak English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance early diabetes detection after childbirth.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for postpartum diabetes screening?

Research has shown that performing an oral glucose tolerance test (OGTT) immediately after childbirth is safe for checking diabetes. This test is as effective as the standard OGTT conducted 4-12 weeks postpartum. A recent study found that 92% of participants completed the test on the second day after delivery, suggesting that more people can complete the test at this time, potentially aiding in early diabetes detection.

Overall, the OGTT immediately after birth appears safe and effective. Studies reviewed have not identified any additional safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about immediate inpatient postpartum OGTT for screening gestational diabetes because it offers a quick and efficient way to identify postpartum diabetes risk before new moms even leave the hospital. Unlike the standard outpatient approach, which involves waiting 4-12 weeks to conduct the test, this method allows for immediate action and potentially faster intervention. This approach could streamline postpartum care and help manage diabetes risk more effectively, providing peace of mind for new mothers.

What evidence suggests that this trial's treatments could be effective for postpartum diabetes screening?

Research has shown that testing for diabetes immediately after childbirth, while still in the hospital, can be effective for women who had gestational diabetes. In this trial, one group of participants will receive the Immediate inpatient postpartum OGTT, which identifies those at risk for type 2 diabetes more effectively than waiting a few weeks after delivery. Testing during the hospital stay results in more women completing the test, with all participants taking part compared to just over half when done later as an outpatient. This method could help detect diabetes early, allowing for quicker follow-up and care. ^{2 6 7 8 9}

Who Is on the Research Team?

Christine Field, MD, MPH

Principal Investigator

Ohio State University

Kartik K Venkatesh, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking individuals who were diagnosed with gestational diabetes during pregnancy, are at least 18 years old, and can give informed consent. They must be receiving care at OSU and be immediately postpartum during their delivery hospital stay. Those with a history of gastric bypass or unable to tolerate an OGTT cannot participate.

Inclusion Criteria

You had high blood sugar during pregnancy, as shown by a glucose test.

Receiving prenatal and postpartum care at OSU

You are in the hospital right after having a baby.

Exclusion Criteria

You cannot handle a 2-hour oral glucose tolerance test (OGTT) due to a history of gastric bypass.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Immediate Postpartum OGTT

Participants undergo an immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Immediate

1 visit (in-person)

Standard Care Postpartum OGTT

Participants undergo a 4-12 week outpatient postpartum OGTT as part of standard care

4-12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for risk perception, lifestyle modification, and diabetes status

12 weeks

Electronic surveys

Long-term Follow-up

Participants are monitored for prediabetes or type 2 diabetes and primary care provider visits

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Immediate inpatient postpartum OGTT
• Standard of care 4-12 week postpartum OGTT

Trial Overview The DIP trial is testing if doing a glucose tolerance test (OGTT) right after giving birth in the hospital helps more new moms get screened for diabetes compared to waiting for the standard 4-12 weeks after delivery. Participants will either receive this immediate test or follow the usual care plan.

How Is the Trial Designed?

Group I: Standard of care Experimental Treatment 1 Intervention

Standard of care is 4-12 week outpatient postpartum OGTT

Group II: Immediate inpatient postpartum OGTT Active Control 1 Intervention

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Immediate inpatient postpartum OGTT is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Approved in Canada as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Approved in European Union as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A quality improvement project significantly increased postpartum screening for type 2 diabetes in women with gestational diabetes from 39% to 77% by implementing a team-based guideline and education on ACOG recommendations.

The education session improved the clinical team's understanding of diabetes screening, as evidenced by a pretest score of 57% rising to 99% post-intervention, highlighting the importance of team education in enhancing healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-Based Approach to Managing Postpartum Screening of Women with Gestational Diabetes for Type 2 Diabetes. Bounds, FL., Rojjanasrirat, W., Martin, MA.[2021]

In a study of 294 women with gestational diabetes mellitus (GDM), 25.5% were found to have impaired glucose tolerance (IGT) and 20.1% were diagnosed with type 2 diabetes mellitus (DM) two months after giving birth, indicating a significant risk of persistent glucose abnormalities post-pregnancy.

The DM group was diagnosed earlier during pregnancy and exhibited higher blood glucose levels and insulin usage compared to those with IGT and normal glucose levels, highlighting the need for close monitoring and management of blood sugar levels in women with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum reclassification in women with gestational diabetes and analyzing the high risk factors associated with them]. Wu, LF., Liu, DY., Huang, XH., et al.[2011]

In a study of 749 women with a history of gestational diabetes, 12.7% were found to have impaired glucose regulation (IGR) postpartum, highlighting the importance of glucose monitoring after delivery.

Key risk factors for postpartum IGR included a family history of type 2 diabetes and having all three glucose values exceed the diagnostic threshold during pregnancy, suggesting targeted monitoring and prevention strategies for these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with postpartum impaired glucose regulation in women with previous gestational diabetes. Bianchi, C., de Gennaro, G., Brocchi, A., et al.[2021]

Approximately 50% of women with gestational diabetes mellitus (GDM) underwent postpartum glucose testing within 6 months of delivery, with 46% of those tests occurring during the optimal 6- to 12-week postpartum period.

Among the women tested, 16.3% had impaired fasting glucose or impaired glucose tolerance, and 1.1% were found to have provisional diabetes, indicating a significant risk of persistent glucose intolerance after GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and timing of postpartum glucose testing and sustained glucose dysregulation after gestational diabetes mellitus. Lawrence, JM., Black, MH., Hsu, JW., et al.[2022]

In a study of pregnant women screened for gestational diabetes, those with an isolated abnormal glucose level at 2 hours during the oral glucose tolerance test had the highest incidence of large for gestational age (LGA) babies (20.3%).

The findings indicate that even mild glucose intolerance can lead to increased risks of LGA and macrosomia, particularly in women with elevated glucose levels at 0 and 2 hours, suggesting the need for monitoring and potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated abnormal value during the 3-hour glucose tolerance test: which value is associated with macrosomia? Cok, T., Tarim, E., Bagis, T.[2011]

A study of 152 women with gestational diabetes showed that using a 6-week postnatal fasting plasma glucose test can effectively identify those who need an oral glucose tolerance test (OGTT), with a sensitivity of 100% and specificity of 94%.

Only 10% of women would need to undergo the OGTT if the threshold for testing was set at a fasting glucose level of 6.0 mmol/l or higher, significantly reducing the number of tests performed while still accurately diagnosing postnatal diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A postnatal fasting plasma glucose is useful in determining which women with gestational diabetes should undergo a postnatal oral glucose tolerance test. Holt, RI., Goddard, JR., Clarke, P., et al.[2019]

Sending reminders to both patients and their physicians significantly increased the rate of postpartum oral glucose tolerance tests (OGTT) in women with previous gestational diabetes, with 60.5% of women in that group getting screened.

Overall, any form of reminder (to patient, physician, or both) led to higher screening rates compared to no reminders, highlighting the effectiveness of reminders in improving postpartum diabetes screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do postal reminders increase postpartum screening of diabetes mellitus in women with gestational diabetes mellitus? A randomized controlled trial. Clark, HD., Graham, ID., Karovitch, A., et al.[2022]

The systematic review included 17 studies and found that both elevated fasting blood glucose and 2-hour OGTT values are significantly associated with an increased risk of developing diabetes in women with gestational diabetes, with odds ratios of 3.62 and 3.96, respectively.

However, these associations were less clear when adjusting for confounding factors, indicating that further research is necessary to establish definitive clinical recommendations regarding the use of antepartum OGTT in predicting diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between the antepartum oral glucose tolerance test and the risk of future diabetes mellitus among women with gestational diabetes: A systematic review and meta-analysis. Moore, LE., Voaklander, B., Savu, A., et al.[2021]

The 75 g 2-hour oral glucose tolerance test (OGTT) conducted 48-72 hours after delivery is effective in identifying women with gestational diabetes mellitus (GDM) who may develop diabetes, showing a high negative predictive value (97.9%) for ruling out diabetes.

The study found that using specific cutoff values for fasting plasma glucose (78 mg/dl) and 2-hour OGTT (130 mg/dl) can help screen for diabetes with reasonable sensitivity (71.4% and 85.7%, respectively), indicating that early postpartum testing can be a valuable strategy for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early diabetes screening in women with previous gestational diabetes: a new insight. Nabuco, A., Pimentel, S., Cabizuca, CA., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121152400544X

Can we do better with postpartum diabetes screening? Immediate postpartum FPG testing effectively excludes low-risk GDM women with regards to future type-2 diabetes and reasonably excluded future glucose ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7206508/

Should women with gestational diabetes be screened at ... These data suggest an oral glucose tolerance test during the delivery hospitalization may reasonably exclude type 2 diabetes. However, the limitations of the ...

3. journals.lww.com journals.lww.com/ogopen/fulltext/2024/09000/administration_of_the_postpartum_glucose_tolerance.17.aspx

Administration of the Postpartum Glucose Tolerance Test... This meta-analysis demonstrates a lower noncompletion rate for screening for type 2 diabetes in individuals with GDM in the immediate postpartum period.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04199676

Immediate Postpartum Glucose Tolerance Testing | ... The objective of this study is to compare the accuracy of a 2hr glucose tolerance test administered during the postpartum hospitalization with the standard of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5790595/

Early versus 6–12 week Postpartum Glucose Tolerance ... The routine 6–12 week postpartum GTT was considered the gold standard. Results. The early GTT was completed by 100% of subjects while only 31 of 58 (53%) women ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05909046

Study Details | NCT05909046 | A Randomized Controlled ... An immediate OGTT has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum OGTT.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5581263/

Optimizing Postpartum Care for the Patient with Gestational ... A recent study showed that performing the OGTT on postpartum day 2 resulted in 92% test completion, which is among the highest reported test completion rates ...

8. withpower.com withpower.com/trial/phase-diabetes-gestational-6-2023-4dd05

Postpartum Diabetes Screening for Gestational Diabetes The Immediate inpatient postpartum OGTT is unique because it involves conducting the oral glucose tolerance test (OGTT) within 48-72 hours after delivery, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506082/

Postpartum diabetes screening for women with gestational ... The outcome was defined as the rate of 75 g OGTT conducted between 6 and 12 weeks postpartum. The 75 g OGTT was identified by the Japanese ...