Group vs. Traditional Diabetes Prenatal Care

NCT ID: NCT03080337

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2018-02-22

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.

Conditions

Pregnancy; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Traditional Care

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 Type: NO_INTERVENTION

No interventions assigned to this group

Group Care

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.

Group Type: EXPERIMENTAL

Group Care

Intervention Type: OTHER

Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.

Interventions

Group Care

Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akron Children's Hospital

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kara Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A532860

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/OBSTET & GYNECOL/OBSTET

Identifier Type: OTHER

Identifier Source: secondary_id

2016-015

Identifier Type: -

Identifier Source: org_study_id