Group vs. Traditional Diabetes Prenatal Care

University of Wisconsin (UW)

Status: Terminated

Conditions: Diabetes; Pregnancy

Treatments: Other: Group Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03080337

2016-015

A532860 (Other Identifier)

SMPH/OBSTET & GYNECOL/OBSTET (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Traditional Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Group Care