Diabetes Group Prenatal Care
- Conditions
- Gestational DiabetesPregnancyType 2 Diabetes
- Interventions
- Behavioral: Group prenatal care
- Registration Number
- NCT02444325
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group prenatal care 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Birthweight delivery admission Determine the effect of group prenatal care on birthweight
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
Contraception 4-12 weeks postpartum Determine the effect of group prenatal care on initiating contraception
Gestational age at delivery delivery admission Determine the effect of group prenatal care on preterm delivery
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
Breastfeeding 4-12 weeks postpartum Determine the effect of group prenatal care on initiating breastfeeding
Trial Locations
- Locations (2)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Denver Health
🇺🇸Denver, Colorado, United States