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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial study visit (22-34weeks) through one year postpartum
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Diabetes Group Care on maternal glycemic control
Effect of Diabetes Group Care on postpartum weight retention
Secondary outcome measures
Completion of self-care activities
Effect of Diabetes Group Care on number of blood glucose values
Maternal Antepartum Compliance
+26 more

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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,592 Total Patients Enrolled
Ebony B. Carter, MD, MPHPrincipal InvestigatorAssistant Professor, Washington University in St. Louis
Megan Lawlor, MDPrincipal InvestigatorAssistant Professor, Washington University in St. Louis

Media Library

Group prenatal care Clinical Trial Eligibility Overview. Trial Name: NCT03301792 — N/A
Gestational Diabetes Research Study Groups: Group prenatal care, Routine Prenatal Care
Gestational Diabetes Clinical Trial 2023: Group prenatal care Highlights & Side Effects. Trial Name: NCT03301792 — N/A
Group prenatal care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03301792 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aims of this research endeavor?

"The primary purpose of this research is to measure the efficacy of Diabetes Group Care on maternal glycemic control over a period ranging from 6 months pre-pregnancy to 1 year postpartum. As secondary objectives, the team will evaluate percentage of recommended blood glucose values logged since initial visit, adherence to diabetes self-care activities as per The Diabetes Self-Care Activities Scale and finally, neonatal jaundice associated with Diabetes Group Care."

Answered by AI

Is this research opportunity presently accessible to participants?

"As per the information on clinicaltrials.gov, this trial is not presently accepting new participants. Initially advertised in September 2017 and last updated July 2022, although it cannot currently be joined by potential subjects, there are over one thousand three hundred eighty-nine other trials that can still accept applications."

Answered by AI

To what patient profile is this clinical research open?

"117 individuals between the ages of 14 and 50 with type 2 diabetes mellitus are eligible to join this trial."

Answered by AI

Do participants of this medical experiment have to be younger than 35 years old?

"This medical experiment is seeking out individuals between the age of 14 and 50 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Group Versus Traditional Prenatal Care for Diabetes
2017. "Group Versus Traditional Prenatal Care for Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03301792.
~20 spots leftby Aug 2025
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