A Cluster-randomised Trial of a Complex Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth in Women Living in Rural India (SMART Health Pregnancy 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,446
- 试验地点
- 2
- 主要终点
- Change anaemia prevalence in women
研究概览
简要总结
The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India.
The main questions it aims to answer are:
- Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth?
- Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.
详细描述
The primary aim of this study is to determine if the SMARThealth Pregnancy intervention can improve women's health in the year after pregnancy, specifically decrease the prevalence of anaemia by 9% and improve follow-up after a pregnancy affected by diabetes or hypertension. High glucose and blood pressure are the two leading contributors to cardiometabolic risk in women in India, thus it is hypothesised that targeting women identified in pregnancy at high risk of these conditions future risk can be decreased.
This study hypothesize SMARThealth Pregnancy intervention will:
- Decrease anaemia prevalence by 9% in women at 12 months after delivery by improving adherence to the current national government guidelines for iron folic acid supplementation through behavioural change interventions delivered to the woman by the Community Health Worker (CHW): (i) during pregnancy, with referral for iron sucrose injections where indicated; and, (ii) during breastfeeding, and (iii) after breastfeeding.
- Ensure women who develop gestational diabetes mellitus (GDM) are identified during pregnancy with appropriate referral, and followed up after birth and screened for the development of type 2 diabetes.
- Detect women with raised blood pressure during pregnancy, and provide ongoing periodic blood pressure (BP) monitoring after birth to detect ongoing hypertension.
- Provide all women during pregnancy and after birth regular mental health assessment and support leading to improved mental state and wellbeing
- Ensure after birth women are offered and have access to appropriate contraception choices
- Improve communication between different levels of the health system (community, subcenter, Primary health Centre (PHC) and district hospital)
Recruitment commenced in Siddipet district 6 June 2022 and will commence in Haryana 1 January 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor) The investigator and outcomes assessor will be blinded to allocation group. Each cluster will be coded and using a random number generator. The sites will only be unlinked after final database lock after endpoint adjudication for analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For Primary health Centres:
- •located in the selected districts
- •provide pregnancy care
- •chief doctor (or equivalent) agrees to participate
- •For women >12 weeks pregnant
排除标准
- •women who plan to move away and not return to the same village for the next 12 months
- •women unable to understand the local study language
- •Women who do not give consent
结局指标
主要结局
Change anaemia prevalence in women
时间窗: 10-12 months after delivery
Proportion of participants with any degree of anaemia (non-pregnant definition Hb \< 12g/dL) between the intervention and control clusters
次要结局
- Postnatal screening for type 2 diabetes after GDM(10-12 months after delivery)
- Postnatal screening for hypertension after hypertensive disorder of pregnancy(10-12 months after delivery)
- Compliance with iron-folic acid supplements during pregnancy and breastfeeding(10-12 months after delivery)
- De-worming treatment(during pregnancy)
- Point of care Haemoglobin (Hb) testing(10-12 months after delivery)
- Referral of high risk conditions(Six weeks post delivery)
- Hypertension after hypertensive disorder of pregnancy(10-12 months after delivery)
- Dysglycaemia after a pregnancy affected by GDM(10-12 months after delivery)
- Change the proportion of women with moderate and severe anaemia(10-12 months after delivery)
- Postnatal screening for type 2 diabetes after GDM(10-12 months after delivery)
- Postnatal screening for hypertension after hypertensive disorder of pregnancy(10-12 months after delivery)
- Dysglycaemia after a pregnancy affected by GDM(10-12 months after delivery)
- De-worming treatment(during pregnancy)
- Referral of high risk conditions(Six weeks post delivery)
- Compliance with iron-folic acid supplements during pregnancy and breastfeeding(10-12 months after delivery)
- Point of care Haemoglobin (Hb) testing(10-12 months after delivery)
- Hypertension after hypertensive disorder of pregnancy(10-12 months after delivery)