Evaluating the effect of community-based pre-conception care package through trained nurses on pre-conception health, maternal and child health outcomes: a stepped-wedge cluster randomized implementation trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Improvement in Pre-conception health among women from eligible couple as ascertained by the proportion of women who would enter pregnancy in good health without undernutrition, anaemia and depression.
研究概览
简要总结
Initiating interventions before conception have positive effect on maternal and child health. However, evidence on how to deliver Preconception care (PCC) at community level in rural under-resourced settings is lacking. The aim of this study is to evaluate the effect of delivering village level PCC through trained Auxiliary Nurse Midwives (ANMs) using a Social Franchising approach on pre-conception health status among eligible women and maternal and child health outcomes in rural Wardha India.
The study is an open cohort stepped wedge cluster randomized trial (swCRT) with repeated cross-sectional sampling for outcome measurement. Over the duration of study, all 96 villages will be randomized using a computer-generated list of random numbers to intervention and control arm in a stepped wedge manner involving random and sequential crossover of clusters from control to intervention until all clusters are exposed. In the intervention arm, a comprehensive PCC package will be delivered to the registered beneficiaries by trained Auxiliary Nurse Mid-wives (ANMs). The Village Health Nutrition and Sanitation Committees (VHNSC) will be catalysed to act as Social Franchisee for establishing pre-conception clinics in their village. The trained ANMs will deliver the PCC package services to the eligible women through these clinics. The registered beneficiaries will receive active PCC package intervention till conception and then will integrate with routine primary health care services to ensure ante-natal, intra-natal and post-natal care continuum. Community-based events will be undertaken through the VHNSC for creating a social norm. The villages in the control arm will receive the standard package of interventions as per the existing Government health programs. The intervention will be implemented for 2 years. This study will provide evidence and a model for delivering PCC at community level through trained ANMs by utilizing existing platform VHNSC and can inform India’s Reproductive, Maternal, Newborn Child and Adolescent Health (RMNCH+A) programme for maximizing the gains for maternal and child health. If successful, the PCC package can be tested at scale in other rural regions of India
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Only those who give written informed consent for participation in trial will be included in the study.
- •Only those women who are permanent resident of the village and willing to stay in the study area for the next two years will be included.
排除标准
- •The eligible couples wherein either of the partner have adopted any permanent method of contraception will be excluded from the study.
结局指标
主要结局
Improvement in Pre-conception health among women from eligible couple as ascertained by the proportion of women who would enter pregnancy in good health without undernutrition, anaemia and depression.
时间窗: Five time points every six monthly starting after six months of intervention with endline conducted at 36 months. Beyond these a baseline assessment will be conducted.
次要结局
- The secondary outcomes include improved maternal & child health outcomes, such as reductions in stillbirth rate, neonatal mortality rate (NMR), infant mortality rate (IMR), & severe maternal morbidities (e.g., pre-eclampsia, gestational diabetes, maternal depression, hemorrhage, & abortion).
- The secondary outcomes include examining the factors that facilitate or hinder the implementation & use of the PCC package, assessing the feasibility of the intervention using the RE-AIM framework, & estimating the unit cost of delivering community-based PCC services accounting for direct, indirect, & opportunity costs, aiding future policy advocacy for the PCC package.
研究者
Dr Abhishek V Raut
Mahatma Gandhi Institute of Medical Sciences, Sevagram