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Group Prenatal Care for Gestational Diabetes

N/A

Waitlist Available

Led By Ebony B. Carter, MD, MPH

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with type 2 diabetes or gestational diabetes by 2-step method or likely pre-existing type 2 diabetes with specific glucose level criteria during pregnancy and at or before 34 weeks

Be between 18 and 65 years old

Must not have

Diagnosis of type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivery through one year postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will determine if diabetes group prenatal care leads to better glycemic control and less postpartum weight retention in women with type 2 diabetes and gestational diabetes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a different approach to receiving prenatal care rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience varying levels of comfort in a group setting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delivery through one year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delivery through one year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery through one year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of Diabetes Group Care on maternal glycemic control

Effect of Diabetes Group Care on postpartum weight retention

Secondary study objectives

Completion of self-care activities

Effect of Diabetes Group Care on number of blood glucose values

Maternal Antepartum Compliance

+26 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Group prenatal care

2015

N/A

~90

0 / 2Eligibility criteria met