Diabetes, Pregnancy
Conditions
Brief summary
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.
Interventions
OTHERGroup Care
Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.
Sponsors
Akron Children's Hospital
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Clinically confirmed viable pregnancy at the time of enrollment. * Able to provide consent for participation. * Diabetes diagnosed prior to 12 weeks gestation. * Initiation of care by 20 weeks gestation. * Age 18 years or older.
Exclusion criteria
* Not planning to deliver at UnityPoint Health- Meriter Hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with glucose testing over time | 2 years | Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay for delivery (days) | 2 years | Compare maternal hospital length of stay for delivery of participants in the group care model to the control group: a traditional, individual care model. |
| Presence of infection (Y/N) | 2 years | Compare presence of infection in participants in the group care model to the control group: a traditional, individual care model. |
| Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other) | 2 years | Compare type of delivery in participants in the group care model to the control group: a traditional, individual care model. |
| Blood Pressure (mm Hg) | 2 years | Compare blood pressures in participants in the group care model to the control group: a traditional, individual care model. |
| Neonatal Birth Weight (grams) | 2 years | Compare neonatal birth weight of participants in the group care model to the control group: a traditional, individual care model. |
| Maternal Weight Gain (kilograms) | 2 years | Compare maternal weight gain of participants in the group care model to the control group: a traditional, individual care model. |
| Neonatal APGAR Score (0-10) | 2 years | Compare neonatal APGAR score of participants in the group care model to the control group: a traditional, individual care model. |
| Gestational Age at Delivery (weeks) | 2 years | Compare gestational age at delivery of participants in the group care model to the control group: a traditional, individual care model. |
| Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey) | 2 years | Compare pregnancy and diabetes related knowledge of participants in the group care model to the control group: a traditional, individual care model. |
| Patient and care giver satisfaction (survey) | 2 years | Compare satisfaction of participants and their respective providers in the group care model to the control group: a traditional, individual care model. |
| Cost-effectiveness (dollars per hour) | 2 years | Compare cost-effectiveness of the group care model to the control group: a traditional, individual care model. |
| Neonatal Length of stay (days) | 2 years | Compare neonatal length of stay of participants in the group care model to the control group: a traditional, individual care model. |
Countries
United States
Outcome results
None listed