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| ID | Type | Description | Link |
|---|---|---|---|
| A532860 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNECOL/OBSTET | Other Identifier | UW Madison |
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This study is being closed prematurely due to resource availability and agreement constraints with the collaborating research site.
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| Name | Class |
|---|---|
| Akron Children's Hospital | OTHER |
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This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Care | No Intervention | If the participant is randomized to the individual prenatal care model, she will continue to receive individualized care in the prenatal clinic. This includes being seen by both a MFM specialist and possibly an endocrinologist at each prenatal visit. During the prenatal visit, the individual caregivers are responsible for discussing educational topics that they feel are relevant to the patient. Patients are seen every two weeks for Traditional Care. | |
| Group Care | Experimental | If the participant is randomized into the group prenatal care model she will be placed in a group of approximately 6-10 women of approximately the same gestational age. These women will then have sessions scheduled at the same intervals they would have had their traditional prenatal visits, every two weeks until 36 weeks and then weekly until delivery, 12 sessions in total. Each session will last between 90-120 minutes. In the group prenatal care model, the entire visit time will be face to face with a provider and the group. Billing will be done through the standard reimbursement system since the program will follow the schedule of prenatal visits recommended by the American Congress of Obstetricians and Gynecologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Care | Other | Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with glucose testing over time | Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Weight Gain (kilograms) | Compare maternal weight gain of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Length of stay for delivery (days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara Hoppe, DO | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnityPoint Health- Meriter Hospital | Madison | Wisconsin | 53715 | United States |
Data will be shared in a REDCap database with University Hospitals, Cleveland.
At time of study completion for up to 1 year.
De-identified data variables will be shared as this will be a shared enrollment effort.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Compare maternal hospital length of stay for delivery of participants in the group care model to the control group: a traditional, individual care model.
| 2 years |
| Presence of infection (Y/N) | Compare presence of infection in participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other) | Compare type of delivery in participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Blood Pressure (mm Hg) | Compare blood pressures in participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Neonatal Birth Weight (grams) | Compare neonatal birth weight of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Neonatal Length of stay (days) | Compare neonatal length of stay of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Neonatal APGAR Score (0-10) | Compare neonatal APGAR score of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Gestational Age at Delivery (weeks) | Compare gestational age at delivery of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey) | Compare pregnancy and diabetes related knowledge of participants in the group care model to the control group: a traditional, individual care model. | 2 years |
| Patient and care giver satisfaction (survey) | Compare satisfaction of participants and their respective providers in the group care model to the control group: a traditional, individual care model. | 2 years |
| Cost-effectiveness (dollars per hour) | Compare cost-effectiveness of the group care model to the control group: a traditional, individual care model. | 2 years |