Diabetes Group Prenatal Care

The Washington University

Status: Completed

Conditions: Gestational Diabetes; Type 2 Diabetes; Pregnancy

Treatments: Behavioral: Group prenatal care

Study type: Interventional

Funder types: Other

Identifiers

NCT02444325

201503174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Routine Prenatal Care

No Intervention group

Description:

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 prenatal care

Experimental group

Description:

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.

Treatment:

Behavioral: Group prenatal care