Group vs. Traditional Diabetes Prenatal Care

Study Overview
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Brief Summary
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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.

Official Title
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Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.

Conditions
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Pregnancy, Diabetes

Intervention / Treatment
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* Other: Group Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Care<br>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. | |
| Experimental: Group Care<br>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. | Other: Group Care<br>* Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |