Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 435
- 试验地点
- 2
- 主要终点
- Large for Gestational Age (LGA)
研究概览
简要总结
Gestational Diabetes Mellitus (GDM) is significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their families in today's Vietnam handle the condition. Vietnamese women often depend on their extended family for daily life management and access to social and financial resources, hence, an intervention that focuses on informal support and GDM self-care may increase adherence the standard guidelines among pregnant women with GDM in Vietnam and increase neonatal and maternal health outcomes.
详细描述
Background: Across the globe, diabetes mellitus is attaining epidemic proportions, with low- and middle-income countries confronting particularly high burdens. VALID II focuses on gestational diabetes mellitus (GDM), a transitory form of diabetes that presents during pregnancy.
Objectives: To: i) Determine prevalence and risk factors for GDM among pregnant women in Vietnam's Thai Binh province, ii) Measure the associations between GDM and pregnancy complications and outcomes, iii) Understand how pregnant women with GDM and their informal support persons perceive and handle the condition, iv) Co-create, implement, and assess the feasibility of a intervention aiming to enhance the self-care capacities of pregnant women with GDM.
Study setting: Thai Binh, Vietnam
Study design: Intervention study
Study population: 2,000 pregnant women attending antenatal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the overt nature of the intervention, it is not possible to blind the participants, healthcare providers nor the investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy < 28 weeks
- •Singleton and multiple pregnancies
- •Residing in Thai Binh province
- •Speaks and reads Vietnamese
- •Agree to participate voluntarily (informed consent)
排除标准
- •Pre-gestational diabetes (type I or type II)
- •Severe chronic disease
- •Women with GDM in a prior pregnancy are eligible for inclusion into the study.
研究组 & 干预措施
Standard GDM care
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
Self-care with informal support
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
干预措施: Self-care with informal support (Behavioral)
结局指标
主要结局
Large for Gestational Age (LGA)
时间窗: Delivery (up to study month 7 after enrolment/Gestational age 40)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st birthweight chart
Large for Gestational Age (LGA)
时间窗: Delivery (study month 7 after enrolment/Gestational age 40)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st fetal weight formula.
The Feasibility of the Self-care Intervention [Recruitment]
时间窗: Recruitment (study month 0)
Number of Participants eligible for the study who accepted to be included in the intervention arm.
The Feasibility of the Self-care Intervention [Retention]
时间窗: Recruitment to post-partum evaluation (study month 0-10)
Number of Participants included in the self-care intervention group who completed the study (delivery data and post-partum interview).
The Acceptability of the Self-care Intervention
时间窗: Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum
Acceptability will be measured in a combined quantitative and qualitative study. It will be measured quantitatively via 5-point likert scales among the intervention group \[Range: 1-5; Minimum score: 1; Maximum score: 5; Higher score indicates high acceptability\]. It will be assessed qualitatively among a sub-group of the intervention group through a ethnographic study.
次要结局
- Macrosomia(Delivery (study month 7/Gestational age 40))
- Macrosomia (Vietnam)(Delivery (study month 7/Gestational age 40))
- Live-born(Delivery (study month 7/Gestational age 40))
- HbA1c(Study month 3 and 7/Gestational age 24 and 40 (delivery))
- Well-being(Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartum)
- Self-care Agency(Study month 3 and 6/Gestational age 24 and 36)
- Self-care of GDM(Study month 6/Gestational age 36)
- Mode of Delivery(Delivery (study month 7/Gestational age 40))
- Pre-term Birth Below Gestational Age 37+0(Delivery (study month 7/Gestational age 40))
- Gestational Age(Delivery (study month 7/Gestational age 40))
- Birth Weight(Delivery (study month 7/Gestational age 40))
- Small for Gestational Age (SGA)(Delivery (study month 7/Gestational age 40))
- Apgar Score(Delivery (study month 7/Gestational age 40))
- Neonatal Hypoglycemia(Delivery (study month 7/Gestational age 40))
- Maternal Gestational Weight Gain(Study month 0 and 6/Gestational age 12 and 36)
- Breast Feeding Practices(Study month 10 (12 weeks post-partum))
- Post-partum Depression(Study month 3 and 10/Gestational age 24 and 12 weeks postpartum)
- Perceived Social Support(Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartum)
研究者
Thanh Duc Nguyen
Head of International Relations Department
Thai Binh University of Medicine and Pharmacy