Group vs. Traditional Diabetes Prenatal Care

Not Applicable

Terminated

• Conditions: Diabetes; Pregnancy
• Interventions: Other: Group Care

• 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: 2019-12-17
• Last Update Posted: 2019-12-19

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

Arm && Interventions

Group	Intervention	Description
Group Care	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.

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