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Compensation: Varies

Number of Visits: 41

117 Participants Needed

Group Prenatal Care for Gestational Diabetes

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 GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational 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.

Is group prenatal care safe for women with gestational diabetes?

Group prenatal care is generally considered safe and may offer benefits such as improved pregnancy outcomes, higher rates of breastfeeding, and reduced need for medical interventions compared to traditional care.¹ ² ³ ⁴ ⁵

How does group prenatal care differ from other treatments for gestational diabetes?

Group prenatal care is unique because it involves shared medical appointments that focus on patient education, mutual support, and more time with healthcare providers, which can lead to better pregnancy outcomes and higher rates of postpartum follow-up compared to traditional individual care.¹ ² ⁵ ⁶ ⁷

What data supports the effectiveness of the treatment Group prenatal care for Gestational Diabetes?

Research shows that group prenatal care can lead to better pregnancy outcomes, such as higher rates of breastfeeding and less need for medication, compared to traditional care. Women in group care also tend to complete important postpartum tests more often, which can help manage gestational diabetes effectively.¹ ² ³ ⁵ 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

See 2 more

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

See 3 more

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?

2Treatment groups

Experimental Treatment

Active Control

Group I: Group prenatal careExperimental Treatment1 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 CareActive Control1 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.

Find a Clinic Near You

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]