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| Name | Class |
|---|---|
| Denver Health Medical Center | OTHER |
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The investigators primary objective is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities in women with diabetes.
Long term, the investigators aim to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities, which have been associated with improved glycemic control, in women with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Prenatal Care | No 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. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes. | |
| Group prenatal care | Experimental | Group visits will be held every 2 weeks in a continuous cycle through a four 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 4-12 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 2 CenteringPregnancy trained providers at each site and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group prenatal care | Behavioral | Women will receive their prenatal care in a group rather than in the 1:1 traditional manner. |
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| Measure | Description | Time Frame |
|---|---|---|
| effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure | Determine the effect of group prenatal care on maternal diabetes self-care activities as measured by the Diabetes Self-care Activities Measure and confirmed by percentage of recommended blood glucose values completed on logs since initial study visit. | 37-39 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale | Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale | baseline and 4-12 weeks postpartum |
| effect of group prenatal care on perceived social support as assessed by the Social Support Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Methodius G Tuuli, MD, MPH | Assistant Professor, Washington University in St. Louis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health | Denver | Colorado | 80204 | United States | ||
| Washington University in St. Louis |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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Determine the effect of group prenatal care on perceived social support through the Social Support Scale |
| 37-39 weeks |
| Birthweight | Determine the effect of group prenatal care on birthweight | delivery admission |
| Gestational age at delivery | Determine the effect of group prenatal care on preterm delivery | delivery admission |
| Mean 3rd trimester fasting blood glucose | Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose | baseline through delivery |
| Breastfeeding | Determine the effect of group prenatal care on initiating breastfeeding | 4-12 weeks postpartum |
| Contraception | Determine the effect of group prenatal care on initiating contraception | 4-12 weeks postpartum |
| St Louis |
| Missouri |
| 63110 |
| United States |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |