Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
117 participants
INTERVENTIONAL
2017-09-14
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Routine Prenatal Care
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.
No interventions assigned to this group
Group prenatal care
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 prenatal care
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
Interventions
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Group prenatal care
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
Eligibility Criteria
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Inclusion Criteria
2. Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \</= 34 weeks:
1. 1 hour glucose challenge test \>/= 185mg/dL OR
2. A1c \>/= 6.5% OR
3. Fasting plasma glucose \> 126mg/dL (2)
3. Ability to attend group prenatal visit at specified days and times
4. Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days
5. Ability to give informed consent
Exclusion Criteria
2. Type 1 Diabetes
3. Multiple gestation
4. Major fetal anomaly
5. Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
6. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.
18 Years
50 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Megan Lawlor, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor, Washington University in St. Louis
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Countries
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Other Identifiers
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201707118; 201906068 (1001)
Identifier Type: -
Identifier Source: org_study_id