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临床试验/NCT03715218
NCT03715218已完成不适用

Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth

NMP Medical Research Institute1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Change in Post-natal depression

研究概览

简要总结

After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems.

'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primigravida
  • Healthy pregnancy
  • Consent to participate

排除标准

  • Mental Health diagnosis
  • Severe depression or psychosis
  • Substance abuse

研究组 & 干预措施

Mother Touch Program

Experimental

Post natal care provided by trained carer after the birth. 6 weeks of care included massage, special diet, physical and mental relaxations.

干预措施: Mothers Touch Program (Other)

Usual care Program

Other

Usual care and supervision was provided as usual.

干预措施: Usual Care Program (Other)

结局指标

主要结局

Change in Post-natal depression

时间窗: 6 weeks following child birth

Changes were assessed using Edinburgh Postnatal Depression scale

次要结局

  • Change in Quality of Life(6 weeks following child birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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