Group vs. Traditional Diabetes Prenatal Care

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03080337
• Other study ID #: 2016-015
• Secondary ID: A532860SMPH/OBST
• Status: Terminated
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: February 22, 2018

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 22, 2018
• Est. primary completion date: February 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pregnancy

Intervention

Other:
• Group Care
Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.

Locations

Country	Name	City	State
United States	UnityPoint Health- Meriter Hospital	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Akron Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness (dollars per hour)	Compare cost-effectiveness of the group care model to the control group: a traditional, individual care model.	2 years