Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Routine Prenatal Care
- 疾病 / 适应症
- Pregnancy
- 发起方
- Washington University School of Medicine
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Effect of Diabetes Group Care on maternal glycemic control
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.
详细描述
Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase) and the impact on postpartum weight retention (Postpartum Phase).
研究者
入排标准
入选标准
- •English speaking
- •Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \</= 34 weeks:
- •1 hour glucose challenge test \>/= 185mg/dL OR
- •A1c \>/= 6.5% OR
- •Fasting plasma glucose \> 126mg/dL (2)
- •Ability to attend group prenatal visit at specified days and times
- •Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days
- •Ability to give informed consent
排除标准
- •Prior participation in diabetes group care
- •Type 1 Diabetes
- •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.
Group prenatal care
Group visits will be held every 2 weeks in a continuous cycle through a six 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 2-12 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 a health educator 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
结局指标
主要结局
Effect of Diabetes Group Care on maternal glycemic control
时间窗: Initial study visit (22-34 weeks) through one year postpartum
Determine the effect of Diabetes Group care on maternal glycemic control by randomizing women to Diabetes group care or traditional care and compare 1) Mean fasting blood glucose, 2) Mean 1-hour post-prandial blood glucose, and 3) Hemoglobin A1c at delivery, 4-12 weeks postpartum, six months postpartum, one year postpartum
Effect of Diabetes Group Care on postpartum weight retention
时间窗: Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum
Determine the impact of Diabetes Group care on postpartum weight retention in pounds based on postpartum weight retention at one year. Average weight retention will be compared at 4-12 weeks, six months postpartum, and one year postpartum.
次要结局
- Effect of Diabetes Group Care on number of blood glucose values(Initial study visit (22-34 weeks) through 39 weeks gestation)
- Psychosocial Anxiety(Initial study visit (22-34weeks) through one year postpartum)
- Psychosocial Depression(Initial study visit (22-34weeks) through 1 year postpartum)
- Maternal Intrapartum Hypertensive Disease of Pregnancy(Delivery through 4-12 weeks postpartum)
- Neonatal body measurements-Weight(delivery through one year postpartum)
- Neonatal NICU Admission(delivery admission)
- Psychosocial Distress(Initial study visit (22-34 weeks) through 4-12 weeks postpartum)
- Maternal Postpartum Readmission(4-12 weeks postpartum)
- Maternal Postpartum Breastfeeding(4-12 weeks postpartum, six months postpartum, one year postpartum)
- Neonatal Birthweight(delivery admission)
- Neonatal APGAR Scores(delivery admission)
- Neonatal Adiposity and body composition(delivery admission through one year postpartum)
- Neonatal Hypoglycemia(delivery admission)
- Neonatal Outcomes(delivery admission)
- Neonatal Jaundice(delivery admission)
- Psychosocial Stress and Depression(Delivery through postpartum)
- Maternal Intrapartum Mode of Delivery(Delivery through 4-12 weeks postpartum)
- Maternal Postpartum Visit Attendance(4-12 weeks postpartum)
- Maternal Postpartum Contraception(4-12 weeks postpartum, six months postpartum, one year postpartum)
- Neonatal body measurements-Length(delivery through one year postpartum)
- Completion of self-care activities(37-39 weeks gestation)
- Maternal Antepartum Compliance(Initial study visit (22-34weeks) through 4-12 weeks postpartum)
- Maternal Antepartum Physical Activity/Eating Behavior(Initial study visit (22-34weeks) through one year postpartum)
- Maternal Antepartum Weight Gain(Initial study visit (22-34weeks) through delivery)
- Maternal Postpartum Glucose Testing(4-12 weeks postpartum)
- Neonatal Gestational Age(delivery admission)
- Neonatal body measurements-Head Circumference(delivery through one year postpartum)
- Psychosocial Stress(Initial study visit (22-34weeks) and six months postpartum)
- Neonatal Stillbirth Rates(delivery admission)
- Psychosocial Stress(Initial study visit (22-34weeks) through one year postpartum)