Gestational Diabetes, Pregnancy, Type 2 Diabetes
Conditions
Keywords
group prenatal care, CenteringPregnancy, diabetes
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.
Interventions
BEHAVIORALGroup prenatal care
Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
Sponsors
Denver Health Medical Center
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure | 37-39 weeks gestation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of group prenatal care on perceived social support as assessed by the Social Support Scale | 37-39 weeks | Determine the effect of group prenatal care on perceived social support through the Social Support Scale |
| Birthweight | delivery admission | Determine the effect of group prenatal care on birthweight |
| Gestational age at delivery | delivery admission | Determine the effect of group prenatal care on preterm delivery |
| effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale | baseline and 4-12 weeks postpartum | Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale |
| Breastfeeding | 4-12 weeks postpartum | Determine the effect of group prenatal care on initiating breastfeeding |
| Contraception | 4-12 weeks postpartum | Determine the effect of group prenatal care on initiating contraception |
| Mean 3rd trimester fasting blood glucose | baseline through delivery | Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose |
Countries
United States
Outcome results
None listed