Group vs. Traditional Diabetes Prenatal Care

NCT03080337 | Terminated

• 3 other identifiers: 2016-015A532860SMPH/OBSTET & GYNECOL/OBSTET
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Maternal Weight Gain (kilograms)

  2 years

• Length of stay for delivery (days)

  2 years

• Presence of infection (Y/N)

  2 years

• Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)

  2 years

• Blood Pressure (mm Hg)

  2 years

Study Arms (2)

Traditional Care

NO INTERVENTION

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

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

Interventions

Group Care OTHER

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

Group Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not planning to deliver at UnityPoint Health- Meriter Hospital.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Akron Children's Hospital: collaborator

Study Sites (1)

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kara Hoppe, DO

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 15, 2017
• Study Start: March 17, 2017
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: August 22, 2025

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At time of study completion for up to 1 year.
• Access Criteria: De-identified data variables will be shared as this will be a shared enrollment effort.

Locations

US (1)