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临床试验/NCT03937050
NCT03937050已完成不适用

Gestational Diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management

London School of Hygiene and Tropical Medicine2 个研究点 分布在 2 个国家目标入组 16,500 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16,500
试验地点
2
主要终点
GDM screening

研究概览

简要总结

This trial will evaluate a package of three interconnected educational/behavioural interventions aimed at: a) improving knowledge and skills of GDM guidelines and skills of health providers; b) raising awareness of importance of GDM screening among pregnant women and their families; and c) improving confidence and skills in self-management among those diagnosed with GDM. The interventions will be delivered through the medium of film as they are low-cost and scalable, and are particularly suitable for people who are not very literate, making them ideal for low- and middle-income countries (LMICs).

The research will be carried out in Uganda (Entebbe) and India (Bengaluru). A careful contextual analysis will precede the development of a culturally-tailored film-based intervention for each setting, which will be iteratively refined using qualitative research methods till it is fit for purpose. The effectiveness of the intervention will be evaluated in independent cluster randomised trials, involving ~10,000 pregnant women across 30 maternity units at each site. The films will be made available in the intervention arm facilities: for viewing by doctors and nurses at their meetings, for continual screening in waiting areas of antenatal clinics, and during group education sessions (and personal mobile use) for GDM patients. Where video/projection facilities are unavailable, small low-cost projectors will be made available. Control arms will follow usual care practices.

The principal research question is whether a low-cost educational/behavioural intervention delivered through a package of culturally-tailored films can provide scalable improvements in timely detection and management of GDM. This will be evaluated through assessing three endpoints: a) detection of GDM at 32 weeks of; b) glycaemic control (fasting glucose) in women with GDM at ~34 weeks of pregnancy; and c) adverse perinatal outcomes associated with GDM. Interviews will be conducted with women and health providers to help understand how and why the intervention may be (or may not be) successful. The ultimate aim of the project is to contribute to scientific evidence underpinning the use of films in cost-effectively scaling up behavioural interventions in low literacy settings.

研究设计

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

入选标准

  • Pregnant women aged 18 or over attending for antenatal care at participating health facilities.
  • Pregnant women willing and able to give informed consent.

排除标准

  • Pregnant women <18 years
  • No informed consent

结局指标

主要结局

GDM screening

时间窗: 32 weeks of pregnancy

Proportion of women who were tested for GDM at or after 24 weeks of pregnancy. Self-reported via telephone contact.

Mean fasting blood sugar (women with GDM)

时间窗: 34 weeks of pregnancy

Mean fasting blood sugar in women diagnosed with GDM. Measured at clinic visit.

次要结局

  • Adverse perinatal outcomes (composite measure)(28 days postpartum (measured 6 weeks after expected date of delivery (EDD)))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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