A Multi-Centric Randomized Controlled Trial to Assess Effectiveness of the Brief Nursing Intervention for Depression in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 776
- 试验地点
- 4
- 主要终点
- PHQ-9 score depressive symptoms
研究概览
简要总结
This study is a randomized, open label,parallel group, multi-center trial comparing the effectiveness of brief Nursingintervention for depression in pregnancy. The study will be conducted at fourcenters in India for 36 months. A total of 192 pregnant women (at each site) withmild depression will be assessed for the effectiveness of the intervention. Theprimary outcome measures will be PHQ-9 Score after three sessions ofintervention delivered at gap of two weeks. The secondary outcomes will be complications in pregnancy and during delivery, Type and mode of delivery,birth weight, neonatal complications, postnatal complications, feedingpractices, nutritional status, immunization status and physical growth ofthe infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women with spontaneous conception attending the Obstetric and Gynecology (OBG) OPD of the selected Hospital for first trimester antenatal care (ANC) visit 2)Clients planning to follow up for ANC care, delivery and postnatal follow up in the index Hospital.
- •Willing to give consent for participation in the study.
排除标准
- •History of intellectual disability, 2)Already on psychiatric treatment for any mental illness including depression.
结局指标
主要结局
PHQ-9 score depressive symptoms
时间窗: After three sessions of intervention delivered at gap of two weeks.
次要结局
- birth weight, neonatal complications, postnatal complications(0-4 weeks after delivery)
- feeding practices, nutritional and immunization status of the infant(0-6 months after delivery)
- Complications in pregnancy and during delivery(9 months ANC and 4 weeks after delivery)
- Physical, Neuro-developmental growth of Infant, Mother-child interaction(0-6 months after delivery)
- Type and mode of delivery(0-4 weeks after delivery)