Group vs. Traditional Diabetes Prenatal Care

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Pregnancy
• Intervention / Treatment: Other: Group Care

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • UnityPoint Health- Meriter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Akron Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): February 22, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2016-015; A532860 (Other Identifier: UW Madison); SMPH/OBSTET & GYNECOL/OBSTET (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in a REDCap database with University Hospitals, Cleveland.
• IPD Sharing Time Frame: At time of study completion for up to 1 year.
• IPD Sharing Access Criteria: De-identified data variables will be shared as this will be a shared enrollment effort.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No