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临床试验/NCT03080337
NCT03080337终止不适用

Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Compliance with glucose testing over time

研究概览

简要总结

This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •Clinically confirmed viable pregnancy at the time of enrollment.
  • •Able to provide consent for participation.
  • •Diabetes diagnosed prior to 12 weeks gestation.
  • •Initiation of care by 20 weeks gestation.
  • •Age 18 years or older.

排除标准

  • •Not planning to deliver at UnityPoint Health- Meriter Hospital.

研究组 & 干预措施

Traditional Care

No Intervention

If the participant is randomized to the individual prenatal care model, she will continue to receive individualized care in the prenatal clinic. This includes being seen by both a MFM specialist and possibly an endocrinologist at each prenatal visit. During the prenatal visit, the individual caregivers are responsible for discussing educational topics that they feel are relevant to the patient. Patients are seen every two weeks for Traditional Care.

Group Care

Experimental

If the participant is randomized into the group prenatal care model she will be placed in a group of approximately 6-10 women of approximately the same gestational age. These women will then have sessions scheduled at the same intervals they would have had their traditional prenatal visits, every two weeks until 36 weeks and then weekly until delivery, 12 sessions in total. Each session will last between 90-120 minutes. In the group prenatal care model, the entire visit time will be face to face with a provider and the group. Billing will be done through the standard reimbursement system since the program will follow the schedule of prenatal visits recommended by the American Congress of Obstetricians and Gynecologist.

干预措施: Group Care (Other)

结局指标

主要结局

Compliance with glucose testing over time

时间窗: 2 years

Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model.

次要结局

  • Gestational Age at Delivery (weeks)(2 years)
  • Blood Pressure (mm Hg)(2 years)
  • Neonatal Length of stay (days)(2 years)
  • Maternal Weight Gain (kilograms)(2 years)
  • Neonatal Birth Weight (grams)(2 years)
  • Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)(2 years)
  • Patient and care giver satisfaction (survey)(2 years)
  • Length of stay for delivery (days)(2 years)
  • Presence of infection (Y/N)(2 years)
  • Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)(2 years)
  • Neonatal APGAR Score (0-10)(2 years)
  • Cost-effectiveness (dollars per hour)(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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