Diabetes Group Prenatal Care
2018年1月3日 更新者：Washington University School of Medicine
Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
84
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Denver、Colorado、美国、80204
- Denver Health
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University in St. Louis
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：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.
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实验性的：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.
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Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
大体时间：37-39 weeks gestation
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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.
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37-39 weeks gestation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
大体时间：baseline and 4-12 weeks postpartum
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Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale
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baseline and 4-12 weeks postpartum
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effect of group prenatal care on perceived social support as assessed by the Social Support Scale
大体时间：37-39 weeks
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Determine the effect of group prenatal care on perceived social support through the Social Support Scale
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37-39 weeks
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Birthweight
大体时间：delivery admission
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Determine the effect of group prenatal care on birthweight
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delivery admission
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Gestational age at delivery
大体时间：delivery admission
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Determine the effect of group prenatal care on preterm delivery
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delivery admission
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Mean 3rd trimester fasting blood glucose
大体时间：baseline through delivery
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Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose
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baseline through delivery
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Breastfeeding
大体时间：4-12 weeks postpartum
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Determine the effect of group prenatal care on initiating breastfeeding
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4-12 weeks postpartum
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Contraception
大体时间：4-12 weeks postpartum
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Determine the effect of group prenatal care on initiating contraception
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4-12 weeks postpartum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Methodius G Tuuli, MD, MPH、Assistant Professor, Washington University in St. Louis
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年5月1日
初级完成 (实际的)
2017年7月6日
研究完成 (实际的)
2017年9月27日
研究注册日期
首次提交
2015年4月27日
首先提交符合 QC 标准的
2015年5月13日
首次发布 (估计)
2015年5月14日
研究记录更新
最后更新发布 (实际的)
2018年1月5日
上次提交的符合 QC 标准的更新
2018年1月3日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.