Diabetes Group Prenatal Care

Study Overview
=================
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.

Official Title
-----------------
Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial

Conditions
-----------------
Pregnancy, Gestational Diabetes, Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Group prenatal care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Prenatal Care<br>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. | |
| Experimental: Group prenatal care<br>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. | Behavioral: Group prenatal care<br>* Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure | Determine the effect of group prenatal care on maternal diabetes self-care activities as measured by the Diabetes Self-care Activities Measure and confirmed by percentage of recommended blood glucose values completed on logs since initial study visit. | 37-39 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale | Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale | baseline and 4-12 weeks postpartum | 
| effect of group prenatal care on perceived social support as assessed by the Social Support Scale | Determine the effect of group prenatal care on perceived social support through the Social Support Scale | 37-39 weeks | 
| Birthweight | Determine the effect of group prenatal care on birthweight | delivery admission | 
| Gestational age at delivery | Determine the effect of group prenatal care on preterm delivery | delivery admission | 
| Mean 3rd trimester fasting blood glucose | Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose | baseline through delivery | 
| Breastfeeding | Determine the effect of group prenatal care on initiating breastfeeding | 4-12 weeks postpartum | 
| Contraception | Determine the effect of group prenatal care on initiating contraception | 4-12 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
group prenatal care, CenteringPregnancy, diabetes