Group Prenatal Care for Gestational Diabetes

Enrolling by invitation at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Type 1 diabetes, Multiple gestation, Major fetal anomaly, Serious medical comorbidity, Serious psychiatric illness, others

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

Compensation: Varies

Number of Visits: 41

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether group prenatal care can help manage blood sugar levels and reduce post-birth weight gain for women with type 2 diabetes or gestational diabetes. Participants will either attend group sessions that include education on pregnancy, diabetes, and nutrition or receive standard prenatal care. Women with type 2 diabetes or those diagnosed with gestational diabetes who can attend group sessions might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance prenatal care for women with diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that group prenatal care is safe for women with gestational diabetes?

Research has shown that group prenatal care is generally safe for pregnant women with diabetes. Studies have found that women in group prenatal care have similar chances of developing gestational diabetes as those in traditional care. This type of care also helps manage weight gain during pregnancy and supports better breastfeeding rates after birth.

One study found that group prenatal care can help control blood sugar levels for those with diabetes, suggesting it might benefit both pregnancy care and diabetes management. So far, no major safety concerns have been reported with this approach. Overall, group prenatal care appears well-received and could be a safe option for managing diabetes during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about group prenatal care for gestational diabetes because it offers a more holistic approach compared to the standard routine prenatal visits. Unlike traditional care, which typically involves quick check-ups focusing on screening tests and medication adjustments, group prenatal care provides extended two-hour sessions every two weeks. These sessions are designed to foster community support among expectant mothers while delivering comprehensive education on pregnancy, behavioral health, diabetes management, and nutrition. Co-facilitated by a health educator and an obstetric provider, this method aims to empower women with knowledge and peer support, potentially leading to better diabetes management and overall well-being during pregnancy.

What evidence suggests that group prenatal care is effective for gestational diabetes?

Research has shown that group prenatal care, which participants in this trial may receive, benefits pregnant women, particularly those with diabetes. One study found that women in group care gained less weight during pregnancy and were more likely to exclusively breastfeed six weeks postpartum. Another study found that group care helps individuals with diabetes manage their blood sugar more effectively. Additionally, group prenatal care encourages adherence to healthy habits such as eating well, exercising, and taking medication. These findings suggest that group prenatal care could help manage gestational diabetes and improve health outcomes for mothers and babies. ^{1 2 3 6 7}

Who Is on the Research Team?

Megan Lawlor, MD

Principal Investigator

Assistant Professor, Washington University in St. Louis

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant women with type 2 or gestational diabetes, who can attend group prenatal visits and consent to randomization before the 34th week of pregnancy. It's not for those with type 1 diabetes, serious medical or psychiatric conditions, multiple pregnancies, major fetal anomalies, or previous group care participation.

Inclusion Criteria

I can attend group prenatal visits at the specified times.

I was diagnosed with type 2 or gestational diabetes by the 2-step method before 34 weeks of pregnancy.

Ability to give informed consent

Exclusion Criteria

I have been diagnosed with type 1 diabetes.

You have previously taken part in a diabetes group program.

Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antepartum Phase

Participants receive group prenatal care focusing on glycemic control and education on pregnancy, behavioral health, diabetes, and nutrition.

15-17 weeks

Bi-weekly group visits, weekly individual visits starting at 37 weeks

Postpartum Phase

Participants are monitored for postpartum weight retention and other health outcomes.

4-12 weeks

Postpartum visits between 4-12 weeks

Extended Follow-up

Participants are monitored for long-term outcomes such as postpartum weight retention, glucose control, and psychosocial health.

Up to 1 year postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Group prenatal care

Trial Overview

The study is testing if group prenatal care can better manage blood sugar levels and help women with gestational or type 2 diabetes control their postpartum weight compared to traditional one-on-one prenatal care.

How Is the Trial Designed?

Group I: Group prenatal care Experimental Treatment 1 Intervention

Group visits will be held every 2 weeks in a continuous cycle through a six session curriculum. Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet. Groups of 2-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education. Groups will be co-facilitated by a health educator and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.

Group II: Routine Prenatal Care Active Control 1 Intervention

Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty. They will receive consultation with the diabetes educator at diagnosis and as needed. Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The Gestational Diabetes Group Program (GDGP) effectively improved diabetes self-management education for pregnant women, leading to significant increases in knowledge and empowerment regarding their condition.

Participants in the GDGP reported high satisfaction levels and experienced optimal pregnancy outcomes, demonstrating the program's efficacy in supporting underserved populations through an interdisciplinary care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gestational Diabetes Group Program. Nasso, J., McCloskey, C., Nordquist, S., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10466168/

Group vs Individual Prenatal Care and Gestational ...

These findings suggest that individuals receiving both group prenatal care and traditional individual prenatal care had similar risk of developing GD.

2.

ysph.yale.edu

ysph.yale.edu/news-article/group-prenatal-care-intervention-shows-promising-results-in-reducing-adverse-pregnancy-outcomes/

Group Prenatal Care Intervention Shows Promising Results in ...

Key Findings: · Reduced gestational weight gain. · Increased likelihood of exclusive breastfeeding at six weeks postpartum (44.4% group members vs ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7855154/

Pilot Randomized Controlled Trial of Diabetes Group ...

The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes ...

4.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/2/138/157459/Innovating-Diabetes-Care-in-Pregnancy-Do-Group

Do Group Care Models Improve Outcomes and Equity? A ...

There is compelling evidence that SMAs improve glycemic control for nonpregnant patients with diabetes, GPC reduces Black and White health ...

5.

reproductive-health-journal.biomedcentral.com

reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-024-01792-3

Implementation and evaluation of the centering pregnancy ...

The main goal of this study is to implement and evaluate the outcomes of the Centering Pregnancy group care model for pregnant women with diabetes.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02444325

NCT02444325 | Diabetes Group Prenatal Care

Long term, the investigators aim to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control ...

7.

ajog.org

ajog.org/article/S0002-9378(16)31508-3/pdf

Group prenatal care for diabetes: safety in numbers?

We developed a unique GPC model for gestational and pre-gestational DM. We evaluated maternal and fetal outcomes of the model compared to traditional ...