Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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 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.
干预措施: Group prenatal care (Behavioral)
结局指标
主要结局
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
时间窗: 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.
次要结局
- effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale(baseline and 4-12 weeks postpartum)
- Birthweight(delivery admission)
- effect of group prenatal care on perceived social support as assessed by the Social Support Scale(37-39 weeks)
- Contraception(4-12 weeks postpartum)
- Gestational age at delivery(delivery admission)
- Mean 3rd trimester fasting blood glucose(baseline through delivery)
- Breastfeeding(4-12 weeks postpartum)