Group vs. Traditional Diabetes Prenatal Care

Not Applicable

Terminated

• Conditions: Diabetes; Pregnancy

• Registration Number: NCT03080337
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-03-17
• Primary Completion: 2018-02-22
• Study Completion: 2018-02-22
• Status Verified: 2019-12
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compliance with glucose testing over time	2 years	Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (mm Hg)	2 years	Compare blood pressures in participants in the group care model to the control group: a traditional, individual care model.
Neonatal Length of stay (days)	2 years	Compare neonatal length of stay of participants in the group care model to the control group: a traditional, individual care model.
Maternal Weight Gain (kilograms)	2 years	Compare maternal weight gain of participants in the group care model to the control group: a traditional, individual care model.
Neonatal Birth Weight (grams)	2 years	Compare neonatal birth weight of participants in the group care model to the control group: a traditional, individual care model.
Gestational Age at Delivery (weeks)	2 years	Compare gestational age at delivery of participants in the group care model to the control group: a traditional, individual care model.
Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)	2 years	Compare pregnancy and diabetes related knowledge of participants in the group care model to the control group: a traditional, individual care model.
Patient and care giver satisfaction (survey)	2 years	Compare satisfaction of participants and their respective providers in the group care model to the control group: a traditional, individual care model.
Length of stay for delivery (days)	2 years	Compare maternal hospital length of stay for delivery of participants in the group care model to the control group: a traditional, individual care model.
Presence of infection (Y/N)	2 years	Compare presence of infection in participants in the group care model to the control group: a traditional, individual care model.
Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)	2 years	Compare type of delivery in participants in the group care model to the control group: a traditional, individual care model.
Neonatal APGAR Score (0-10)	2 years	Compare neonatal APGAR score of participants in the group care model to the control group: a traditional, individual care model.
Cost-effectiveness (dollars per hour)	2 years	Compare cost-effectiveness of the group care model to the control group: a traditional, individual care model.

Trial Locations

Locations (1)

UnityPoint Health- Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States