Diabetes Group Prenatal Care

NCT ID: NCT02444325

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-09-27

Brief Summary

The investigators primary objective is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities in women with diabetes.

Detailed Description

Long term, the investigators aim to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities, which have been associated with improved glycemic control, in women with diabetes.

Conditions

Pregnancy; Gestational Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine Prenatal Care

Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty. They will receive consultation with the diabetes educator at diagnosis and as needed. Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group prenatal care

Group visits will be held every 2 weeks in a continuous cycle through a four session curriculum. Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet. Groups of 4-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education. Groups will be co-facilitated by 2 CenteringPregnancy trained providers at each site and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.

Group Type: EXPERIMENTAL

Group prenatal care

Intervention Type: BEHAVIORAL

Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.

Interventions

Group prenatal care

Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English (WUMC) or Spanish speaking (DH)
• Type 2 White's Class B diabetes OR gestational diabetes diagnosed by 2-step method < 32 weeks
• Ability to attend group prenatal visit at specified days and times
• Willingness to be randomized
• Randomization at 22 weeks 0 days-32 weeks 0 days
• Ability to give informed consent

Exclusion Criteria

• Multiple gestation
• Major fetal anomaly
• Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider
• Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Denver Health Medical Center

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Methodius G Tuuli, MD, MPH

Role: STUDY_DIRECTOR

Assistant Professor, Washington University in St. Louis

Locations

Denver Health

Denver, Colorado, United States

Washington University in St. Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201503174

Identifier Type: -

Identifier Source: org_study_id